Trial Outcomes & Findings for Efficacy and Safety Study of Moxidectin in Adults With Scabies (NCT NCT05875441)
NCT ID: NCT05875441
Last Updated: 2026-06-16
Results Overview
Complete Cure is defined as demonstration of both: 1. Clinical cure: all signs and symptoms have completely resolved, including burrows, inflammatory/noninflammatory lesions and pruritus. And 2. Microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermoscopy for burrows.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
28 Days
Results posted on
2026-06-16
Participant Flow
The study was open to recruitment on 9 Nov 2023 and the first participant was screened on 14 Nov 2023. Last participant last study visit was completed on 11 Feb 2025.
Participant milestones
| Measure |
Moxidectin 8mg
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP). Moxidectin 8 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind. All subjects except one received the correct dose of assigned IP (moxidectin 8 mg).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing. Moxidectin 16 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind. Of 49 subjects exposed to study IP, 48 subjects received the correct dose of assigned IP (moxidectin 16 mg), one subject received the incorrect dose.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP. Moxidectin 32 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received 16 capsules of moxidectin 2 mg over encapsulated tablets.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP. Placebo capsules were administered as a single dose on Day 0. Each subject received the 16 capsules of placebo.
Placebo: 16 placebo capsules were administered as a single dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
51
|
49
|
|
Overall Study
Full Analysis Set
|
50
|
49
|
51
|
49
|
|
Overall Study
Per Protocol Analysis Set
|
49
|
47
|
51
|
48
|
|
Overall Study
Safety Analysis Set
|
50
|
49
|
51
|
49
|
|
Overall Study
Complete Analysis Set
|
50
|
48
|
51
|
48
|
|
Overall Study
COMPLETED
|
50
|
48
|
50
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Moxidectin 8mg
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP). Moxidectin 8 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind. All subjects except one received the correct dose of assigned IP (moxidectin 8 mg).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing. Moxidectin 16 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind. Of 49 subjects exposed to study IP, 48 subjects received the correct dose of assigned IP (moxidectin 16 mg), one subject received the incorrect dose.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP. Moxidectin 32 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received 16 capsules of moxidectin 2 mg over encapsulated tablets.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP. Placebo capsules were administered as a single dose on Day 0. Each subject received the 16 capsules of placebo.
Placebo: 16 placebo capsules were administered as a single dose.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal prior to dosing
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Moxidectin in Adults With Scabies
Baseline characteristics by cohort
| Measure |
Moxidectin 8mg
n=50 Participants
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP). Moxidectin 8 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind. All subjects except one received the correct dose of assigned IP (moxidectin 8 mg).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
n=49 Participants
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing. Moxidectin 16 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind. Of 49 subjects exposed to study IP, 48 subjects received the correct dose of assigned IP (moxidectin 16 mg), one subject received the incorrect dose.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
n=51 Participants
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP. Moxidectin 32 mg (over encapsulated) was administered as a single dose on Day 0. All subjects received the assigned treatment.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
n=49 Participants
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP. Placebo capsules were administered as a single dose on Day 0. All subjects received the assigned treatment.
Placebo: 16 placebo capsules were administered as a single dose.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
32 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
31 Participants
n=6 Participants
|
128 Participants
n=7 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=20 Participants
|
45 Participants
n=20 Participants
|
48 Participants
n=40 Participants
|
45 Participants
n=6 Participants
|
185 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
14 Participants
n=7 Participants
|
|
Age, Continuous
|
38.0 Years
STANDARD_DEVIATION 14.80 • n=20 Participants
|
42.6 Years
STANDARD_DEVIATION 15.57 • n=20 Participants
|
43.6 Years
STANDARD_DEVIATION 14.29 • n=40 Participants
|
42.9 Years
STANDARD_DEVIATION 17.90 • n=6 Participants
|
41.8 Years
STANDARD_DEVIATION 15.72 • n=7 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
18 Participants
n=6 Participants
|
71 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=20 Participants
|
49 Participants
n=20 Participants
|
49 Participants
n=40 Participants
|
45 Participants
n=6 Participants
|
192 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
14 Participants
n=6 Participants
|
52 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
35 Participants
n=6 Participants
|
147 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Dominican Republic
|
9 participants
n=20 Participants
|
11 participants
n=20 Participants
|
15 participants
n=40 Participants
|
13 participants
n=6 Participants
|
48 participants
n=7 Participants
|
|
Region of Enrollment
El Salvador
|
18 participants
n=20 Participants
|
14 participants
n=20 Participants
|
14 participants
n=40 Participants
|
15 participants
n=6 Participants
|
61 participants
n=7 Participants
|
|
Region of Enrollment
Honduras
|
16 participants
n=20 Participants
|
18 participants
n=20 Participants
|
15 participants
n=40 Participants
|
15 participants
n=6 Participants
|
64 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=20 Participants
|
6 participants
n=20 Participants
|
7 participants
n=40 Participants
|
6 participants
n=6 Participants
|
26 participants
n=7 Participants
|
|
Body Mass Index
Underweight (<18.5)
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Body Mass Index
Healthy weight (≥ 18.5 to < 25)
|
14 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
61 Participants
n=7 Participants
|
|
Body Mass Index
Overweight (≥25 to < 30)
|
26 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
22 Participants
n=6 Participants
|
89 Participants
n=7 Participants
|
|
Body Mass Index
Obese (≥ 30)
|
10 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
12 Participants
n=6 Participants
|
48 Participants
n=7 Participants
|
|
Baseline Scabies Disease Characteristics - Scabies Severity
Mild (≤ 10 lesions)
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
15 Participants
n=7 Participants
|
|
Baseline Scabies Disease Characteristics - Scabies Severity
Moderate (≥ 11 and ≤ 49 lesions)
|
34 Participants
n=20 Participants
|
35 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
34 Participants
n=6 Participants
|
145 Participants
n=7 Participants
|
|
Baseline Scabies Disease Characteristics - Scabies Severity
Severe (≥ 50 lesions)
|
13 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
39 Participants
n=7 Participants
|
|
Baseline Scabies Disease Characteristics: Mean Number of lesions
|
34.4 Number of lesions
STANDARD_DEVIATION 25.83 • n=20 Participants
|
29.8 Number of lesions
STANDARD_DEVIATION 19.00 • n=20 Participants
|
25.8 Number of lesions
STANDARD_DEVIATION 17.77 • n=40 Participants
|
28.9 Number of lesions
STANDARD_DEVIATION 18.44 • n=6 Participants
|
29.7 Number of lesions
STANDARD_DEVIATION 20.60 • n=7 Participants
|
|
Baseline Scabies Disease Characteristics Number body regions affected
|
3.7 Number body regions affected
STANDARD_DEVIATION 1.71 • n=20 Participants
|
3.4 Number body regions affected
STANDARD_DEVIATION 1.38 • n=20 Participants
|
3.3 Number body regions affected
STANDARD_DEVIATION 1.55 • n=40 Participants
|
3.6 Number body regions affected
STANDARD_DEVIATION 1.29 • n=6 Participants
|
3.5 Number body regions affected
STANDARD_DEVIATION 1.49 • n=7 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The Full Analysis Set defined as all randomized index subjects receiving study drug and analyzed according to the treatment group to which they were randomized.
Complete Cure is defined as demonstration of both: 1. Clinical cure: all signs and symptoms have completely resolved, including burrows, inflammatory/noninflammatory lesions and pruritus. And 2. Microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermoscopy for burrows.
Outcome measures
| Measure |
Moxidectin 8mg
n=50 Participants
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
n=49 Participants
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
n=51 Participants
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
n=49 Participants
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Placebo: 16 placebo capsules were administered as a single dose.
|
|---|---|---|---|---|
|
Percentage of Index Subjects Achieving Complete Cure (Efficacy)
|
28 Participants
|
31 Participants
|
32 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Week 16 inclusive.Population: Safety was analyzed using the Safety Analysis Set (SfAS) defined as all index subjects exposed to IP. For the SfAS, subjects were analyzed as per the actual treatment received regardless of their randomized group. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for SfAS. Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
Incidence and severity of Treatment Emergent Adverse Event (TEAEs), Incidence of serious TEAEs and Incidence of TEAEs leading to study withdrawal and/or death. The analysis of adverse events (AEs) was focused on treatment emergent adverse events (TEAEs), defined as AEs that started, or worsened, on or after the start of the administration of IP.
Outcome measures
| Measure |
Moxidectin 8mg
n=50 Participants
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
n=48 Participants
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
n=52 Participants
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
n=49 Participants
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Placebo: 16 placebo capsules were administered as a single dose.
|
|---|---|---|---|---|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of Participants with Grade 2 TEAE
|
2 participants
|
1 participants
|
4 participants
|
1 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Any TEAEs leading to death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of Participants with TEAE considered Unrelated to study drug (unrelated or unlikely related)
|
5 participants
|
3 participants
|
4 participants
|
5 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs)
|
9 participants
|
5 participants
|
11 participants
|
8 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of Participants with Grade 1 TEAE
|
7 participants
|
4 participants
|
7 participants
|
7 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of Participants with Grade 3 or Grade 4 TEAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of Participants with TEAE defined as Serious
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of participants with TEAE leading to Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of Participants with a TEAE leading to withdrawal from study
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Event (Safety)
Number of Participants with TEAE Related to study drug (possibly, probably and definitely related)
|
4 participants
|
2 participants
|
7 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 DaysPopulation: Analysis population includes all randomized index subjects receiving study drug and analyzed according to the treatment group to which they were randomized. Subjects with missing data were excluded from the analysis for this outcome measure.
The Percentage of index subjects demonstrating clinical cure without microscopic or dermatoscopic cure at Day 28, assessed by skin examination to confirm all signs of scabies have completely resolved.
Outcome measures
| Measure |
Moxidectin 8mg
n=50 Participants
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
n=48 Participants
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
n=51 Participants
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
n=48 Participants
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Placebo: 16 placebo capsules were administered as a single dose.
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving Day 28 Cure Rates: Clinical Cure
|
28 Participants
|
31 Participants
|
32 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 DaysPopulation: Analysis population includes all randomized index subjects receiving study drug and analyzed according to the treatment group to which they were randomized. Subjects with missing data were excluded from the analysis for this outcome measure.
The Percentage of index subjects demonstrating microscopic or dermatoscopic cure without clinical cure at Day 28. Microscopic or dermatoscopic cure is assessed by demonstrating the absence of scabies mites, eggs, and/or scybala, and negative dermoscopy for burrows.
Outcome measures
| Measure |
Moxidectin 8mg
n=50 Participants
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
n=48 Participants
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
n=51 Participants
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
n=48 Participants
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Placebo: 16 placebo capsules were administered as a single dose.
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving Day 28 Cure Rates: Microscopic or Dermatoscopic Cure Without Clinical Cure.
|
40 Participants
|
39 Participants
|
43 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28Population: Analysis population includes all randomized index subjects receiving study drug and analyzed according to the treatment group to which they were randomized. Subjects with missing data were excluded from the analysis for this outcome measure.
The Percentage of index subjects demonstrating cure as assessed by the Investigator at Day 28.
Outcome measures
| Measure |
Moxidectin 8mg
n=50 Participants
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
n=48 Participants
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
n=51 Participants
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
n=48 Participants
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP.
Placebo: 16 placebo capsules were administered as a single dose.
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Day 28 Cure Rates: Investigator Assessed Cure
Scabies infestation is clear with all signs resolved
|
31 Participants
|
32 Participants
|
32 Participants
|
1 Participants
|
|
Percentage of Subjects Reporting Day 28 Cure Rates: Investigator Assessed Cure
Scabies infestation is clear with incomplete resolution of signs, no SOC treatment warranted
|
10 Participants
|
10 Participants
|
13 Participants
|
3 Participants
|
|
Percentage of Subjects Reporting Day 28 Cure Rates: Investigator Assessed Cure
Scabies infestation is not clear and additional treatment with standard of care is warranted
|
9 Participants
|
6 Participants
|
6 Participants
|
44 Participants
|
Adverse Events
Moxidectin 8mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Moxidectin 16mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Moxidectin 32mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moxidectin 8mg
n=50 participants at risk
Fifty index subjects were randomized to moxidectin 8 mg treatment group and exposed to Investigational Product (IP). Moxidectin 8 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind. All subjects except one received the correct dose of assigned IP (moxidectin 8 mg).
Moxidectin Oral Product: 8 mg oral tablets.
|
Moxidectin 16mg
n=48 participants at risk
Fifty index subjects were randomized to moxidectin 16 mg treatment group. Forty nine subjects were exposed to Investigational Product (IP). One subject did not receive the IP as they withdrew from study prior to dosing. Moxidectin 16 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received the same number of capsules made up of moxidectin 2 mg over encapsulated tablets and placebo capsules to maintain the blind. Of 49 subjects exposed to study IP, 48 subjects received the correct dose of assigned IP (moxidectin 16 mg), one subject received the incorrect dose.
Moxidectin Oral Product: 16 mg oral tablets.
|
Moxidectin 32mg
n=52 participants at risk
Fifty one index subjects were randomized to moxidectin 32 mg treatment group. All 51 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for SfAS. Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module. Moxidectin 32 mg (over encapsulated) was administered as a single dose on Day 0. Each subject received 16 capsules of moxidectin 2 mg over encapsulated tablets.
Moxidectin Oral Product: 32 mg oral tablets.
|
Placebo
n=49 participants at risk
Forty nine index subjects were randomized to placebo group. All 49 subjects were exposed to Investigational Product (IP) and received the correct dose of assigned IP. Placebo capsules were administered as a single dose on Day 0. Each subject received the 16 capsules of placebo.
Placebo: 16 placebo capsules were administered as a single dose.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.1%
1/48 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
7.7%
4/52 • Number of events 4 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
2/50 • Number of events 2 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
9.6%
5/52 • Number of events 5 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Infections and infestations
Influenza
|
6.0%
3/50 • Number of events 3 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.1%
1/48 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
1.9%
1/52 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.1%
1/48 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
3.8%
2/52 • Number of events 2 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Nervous system disorders
Taste disorder
|
2.0%
1/50 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
5.8%
3/52 • Number of events 3 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/50 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
1.9%
1/52 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
1.9%
1/52 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
1.9%
1/52 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.1%
1/48 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
1.9%
1/52 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Investigations
Blood urea decreased
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.1%
1/48 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.0%
1/49 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.1%
1/48 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
2.1%
1/48 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/52 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/50 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/48 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
1.9%
1/52 • Number of events 1 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
0.00%
0/49 • Day 0 to Week 16, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. One subject randomized to moxidectin 16 mg was administered moxidectin 32 mg dose, hence was included in moxidectin 32mg group for Safety Analysis Set (SfAS). Therefore, the Overall Number of Participants Analyzed in the "Moxidectin 32mg" Arm is 52 instead of 51 as recorded in the Participant Flow module.
|
Additional Information
Clinical Project Manager
Medicines Development for Global Health
Phone: +61 3 99122400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution agrees that no Publication of the Study results may be made until Publication of the results of the Study or 2 years after Study Completion, whichever is the sooner.The Institution must ensure that the Discloser gives a copy of any proposed Publication drafted by them and/or other Personnel involved in the conduct of the Study to the Sponsor at least 40 days before forwarding it to any person that is not bound by the confidentiality obligations.
- Publication restrictions are in place
Restriction type: OTHER