Trial Outcomes & Findings for Evaluation of Immediate-Release Viloxazine in Adults With ADHD (NCT NCT01107496)
NCT ID: NCT01107496
Last Updated: 2024-10-15
Results Overview
The percent of subjects who took at least one dose of immediate-release viloxazine (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population
COMPLETED
PHASE1/PHASE2
52 participants
Weeks 1-6
2024-10-15
Participant Flow
Participant milestones
| Measure |
IR Viloxazine
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
Dosed
|
26
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
IR Viloxazine
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Evaluation of Immediate-Release Viloxazine in Adults With ADHD
Baseline characteristics by cohort
| Measure |
IR Viloxazine
n=26 Participants
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 Participants
Treatment B: Placebo administered orally 3 times a day
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 14.04 • n=99 Participants
|
43.1 years
STANDARD_DEVIATION 10.39 • n=107 Participants
|
40.4 years
STANDARD_DEVIATION 12.56 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Height
|
66.740 inches
STANDARD_DEVIATION 3.5103 • n=99 Participants
|
68.406 inches
STANDARD_DEVIATION 4.0851 • n=107 Participants
|
67.557 inches
STANDARD_DEVIATION 3.8573 • n=206 Participants
|
|
Weight
|
163.85 pounds (lbs)
STANDARD_DEVIATION 33.641 • n=99 Participants
|
171.05 pounds (lbs)
STANDARD_DEVIATION 33.057 • n=107 Participants
|
167.38 pounds (lbs)
STANDARD_DEVIATION 33.221 • n=206 Participants
|
|
BMI
|
25.688 kilograms per square meter
STANDARD_DEVIATION 3.7216 • n=99 Participants
|
25.664 kilograms per square meter
STANDARD_DEVIATION 4.3620 • n=107 Participants
|
25.676 kilograms per square meter
STANDARD_DEVIATION 4.0073 • n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 1-6Population: Safety Population (N), defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication.
The percent of subjects who took at least one dose of immediate-release viloxazine (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population
Outcome measures
| Measure |
IR Viloxazine
n=26 Participants
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 Participants
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Incidence of Adverse Events During 6 Weeks of Treatment
|
88.5 percentage of subjects
|
72.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent-to-Treat (ITT) Population (N), defined as subjects who were randomly assigned to one of two treatment groups, took at least one dose of study medication, had a valid baseline CAARS assessment (pre-dosing), and had at least one valid post-baseline CAARS assessment.
The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (\<0) represents a better outcome.
Outcome measures
| Measure |
IR Viloxazine
n=26 Participants
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 Participants
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6 (End of Study)
Raw score; Baseline
|
36.0 units on a scale
Interval 20.0 to 54.0
|
35.0 units on a scale
Interval 21.0 to 45.0
|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6 (End of Study)
Change from Baseline score; Week 6
|
-11.5 units on a scale
Interval -38.0 to 4.0
|
-6.0 units on a scale
Interval -34.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline and Week 1Population: Intent-to-Treat (ITT) Population (N), defined as subjects who were randomly assigned to one of two treatment groups, took at least 1 dose of study medication, had a valid baseline CAARS assessment (pre-dosing), and had at least one valid post-baseline CAARS assessment.
The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (\<0) represents a better outcome.
Outcome measures
| Measure |
IR Viloxazine
n=26 Participants
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 Participants
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 1
Raw score; Baseline
|
36.0 units on a scale
Interval 20.0 to 54.0
|
35.0 units on a scale
Interval 21.0 to 45.0
|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 1
Change from Baseline score; Week 1
|
-5.0 units on a scale
Interval -29.0 to 1.0
|
-2.0 units on a scale
Interval -25.0 to 7.0
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, and 6Population: Intent-to-Treat (ITT) Population (N), defined as subjects who were randomly assigned to one of two treatment groups, took at least 1 dose of study medication, had a valid CGI-S assessment at baseline, and had at least one valid post-baseline CGI-I assessment.
The Global Clinical Impression-Improvement (CGI-I) scale is a single item clinician-rated assessment of how much the subject's condition (symptoms) has improved, worsened, or has not changed relative to his/her baseline state prior to the beginning of treatment; it is rated on a 7-point scale from 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The Clinical Global Impression-Severity of Illness (CGI-S) score is a single item clinician-rated assessment of the severity of subject's condition (symptoms) in relation to the clinician's total experience with patients with ADHD; it is rated on a 7-point scale with 1=Normal, not at all ill, 2=Borderline Ill, 3=Mildly Ill, 4=Moderately Ill, 5=Markedly Ill, 6=Severely Ill, 7=Among the most extremely ill patients. CGI-I scores at post-baseline visits were subtracted from CGI-S score at baseline; a change from baseline score \<0 represent better outcome.
Outcome measures
| Measure |
IR Viloxazine
n=26 Participants
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 Participants
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Change from "Baseline CGI-S Score"; Week 6
|
-1.0 units on a scale
Interval -3.0 to 4.0
|
0.0 units on a scale
Interval -1.0 to 4.0
|
|
Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Change from "Baseline CGI-S Score"; Week 1
|
0.0 units on a scale
Interval -2.0 to 5.0
|
0.0 units on a scale
Interval -1.0 to 4.0
|
|
Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Change from "Baseline CGI-S Score"; Week 2
|
-1.0 units on a scale
Interval -2.0 to 5.0
|
0.0 units on a scale
Interval -2.0 to 4.0
|
|
Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Change from "Baseline CGI-S Score"; Week 3
|
-1.5 units on a scale
Interval -2.0 to 4.0
|
0.0 units on a scale
Interval -2.0 to 4.0
|
|
Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Change from "Baseline CGI-S Score"; Week 4
|
-1.5 units on a scale
Interval -3.0 to 4.0
|
0.0 units on a scale
Interval -2.0 to 5.0
|
|
Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Change from "Baseline CGI-S Score"; Week 5
|
-1.5 units on a scale
Interval -3.0 to 4.0
|
0.0 units on a scale
Interval -2.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 3, 4, and 5Population: Intent-to-Treat (ITT) Population (N), defined as subjects who were randomly assigned to one of two treatment groups, took at least 1 dose of study medication, and had a valid baseline CAARS assessment (pre-dosing) and at least one valid post-baseline CAARS assessment.
The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (\<0) represents a better outcome.
Outcome measures
| Measure |
IR Viloxazine
n=26 Participants
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 Participants
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 2, Week 3, Week 4, and Week 5
Raw Score; Baseline
|
36.0 units on a scale
Interval 20.0 to 54.0
|
35.0 units on a scale
Interval 21.0 to 45.0
|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 2, Week 3, Week 4, and Week 5
Change from Baseline score; Week 2
|
-8.0 units on a scale
Interval -33.0 to 1.0
|
-6.0 units on a scale
Interval -27.0 to 6.0
|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 2, Week 3, Week 4, and Week 5
Change from Baseline score; Week 3
|
-13.5 units on a scale
Interval -32.0 to -2.0
|
-6.0 units on a scale
Interval -34.0 to 5.0
|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 2, Week 3, Week 4, and Week 5
Change from Baseline score; Week 4
|
-12.5 units on a scale
Interval -33.0 to -3.0
|
-7.0 units on a scale
Interval -31.0 to 5.0
|
|
Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 2, Week 3, Week 4, and Week 5
Change from Baseline score; Week 5
|
-13.0 units on a scale
Interval -37.0 to 9.0
|
-7.0 units on a scale
Interval -32.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent-to-Treat (ITT) Population (N), defined as subjects who were randomly assigned to one of two treatment groups, took at least 1 dose of study medication, and had a valid baseline CAARS assessment (pre-dosing) and at least one valid post-baseline CAARS assessment.
The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (\<0) represents a better outcome.
Outcome measures
| Measure |
IR Viloxazine
n=26 Participants
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 Participants
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Change From Baseline in the Self-rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6
Raw score; Baseline
|
35.0 units on a scale
Interval 7.0 to 49.0
|
34.0 units on a scale
Interval 13.0 to 48.0
|
|
Change From Baseline in the Self-rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6
Change from Baseline score; Week 6
|
-10.5 units on a scale
Interval -46.0 to 7.0
|
-1.0 units on a scale
Interval -35.0 to 8.0
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, and 6Population: Intent-to-Treat (ITT) Population (N), defined as subjects who were randomly assigned to one of two treatment groups, took at least 1 dose of study medication, and at least one valid post-baseline CGI-I assessment.
The Global Clinical Impression-Improvement (CGI-I) scale is a single item clinician-rated assessment of how much the subject's condition (symptoms) has improved, worsened, or has not changed relative to his/her baseline state prior to the beginning of treatment; it is rated on a 7-point scale from 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. A CGI-I score \<4 represents a better outcome.
Outcome measures
| Measure |
IR Viloxazine
n=26 Participants
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 Participants
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Week 1
|
5.0 units on a scale
Interval 3.0 to 7.0
|
5.0 units on a scale
Interval 3.0 to 6.0
|
|
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Week 2
|
4.0 units on a scale
Interval 3.0 to 6.0
|
5.0 units on a scale
Interval 2.0 to 6.0
|
|
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Week 3
|
3.5 units on a scale
Interval 3.0 to 5.0
|
5.0 units on a scale
Interval 2.0 to 6.0
|
|
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Week 4
|
4.0 units on a scale
Interval 2.0 to 5.0
|
5.0 units on a scale
Interval 2.0 to 6.0
|
|
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Week 5
|
4.0 units on a scale
Interval 2.0 to 5.0
|
5.0 units on a scale
Interval 2.0 to 6.0
|
|
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Week 6
|
3.5 units on a scale
Interval 2.0 to 5.0
|
5.0 units on a scale
Interval 2.0 to 6.0
|
Adverse Events
IR Viloxazine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IR Viloxazine
n=26 participants at risk
Treatment A: Immediate-release (IR) viloxazine capsules administered orally 3 times a day
|
Placebo
n=25 participants at risk
Treatment B: Placebo administered orally 3 times a day
|
|---|---|---|
|
Eye disorders
Dry eye
|
7.7%
2/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
0.00%
0/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
8.0%
2/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
23.1%
6/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
12.0%
3/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
3/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
0.00%
0/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
2/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
4.0%
1/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
8.0%
2/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
General disorders
Fatigue
|
11.5%
3/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
4.0%
1/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
General disorders
Irritability
|
11.5%
3/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
4.0%
1/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
16.0%
4/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
8.0%
2/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Investigations
Weight decreased
|
7.7%
2/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
0.00%
0/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.8%
8/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
4.0%
1/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
8.0%
2/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Nervous system disorders
Headache
|
30.8%
8/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
36.0%
9/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Nervous system disorders
Hypogeusia
|
7.7%
2/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
0.00%
0/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Nervous system disorders
Somnolence
|
11.5%
3/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
8.0%
2/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Psychiatric disorders
Abnormal dreams
|
11.5%
3/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
0.00%
0/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Psychiatric disorders
Initial insomnia
|
7.7%
2/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
0.00%
0/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
2/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
0.00%
0/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
|
Psychiatric disorders
Insomnia
|
30.8%
8/26 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
4.0%
1/25 • Weeks 1-6 of Treatment
Safety Population, defined as subjects who were randomly assigned to one of two treatment groups and took at least one dose of study medication
|
Additional Information
Jonathan Rubin, MD, Senior Vice President and Chief Medical Officer
Supernus Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place