Trial Outcomes & Findings for A Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type (NCT NCT02549196)
NCT ID: NCT02549196
Last Updated: 2019-03-05
Results Overview
Of the four cohorts with different dosing schedules for CPC-201, the cohort with the greatest proportion of participants to reach the donepezil MAD was determined to be the optimal administration regimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
1-7 weeks
Results posted on
2019-03-05
Participant Flow
A total of 28 subjects between the chronological ages of 50 and 89 years with dementia of Alzheimer's type were enrolled in the study.
Participant milestones
| Measure |
Cohort 1
Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 2
Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 1b
Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 3c
Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
1
|
6
|
13
|
|
Overall Study
COMPLETED
|
7
|
1
|
5
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 2
Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 1b
Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 3c
Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type
Baseline characteristics by cohort
| Measure |
Cohort 1
n=8 Participants
Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 2
n=1 Participants
Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 1b
n=6 Participants
Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 3c
n=13 Participants
Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Black or African- American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Age, Continuous
|
72 Years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
74 Years
n=107 Participants
|
75.5 Years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
73 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
73.3 Years
STANDARD_DEVIATION 8.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1-7 weeksPopulation: The MTD evaluable population was defined as all patients who completed the donepezil dose titration.
Of the four cohorts with different dosing schedules for CPC-201, the cohort with the greatest proportion of participants to reach the donepezil MAD was determined to be the optimal administration regimen.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 2
n=1 Participants
Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 1b
n=5 Participants
Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 3c
n=12 Participants
Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
|
|---|---|---|---|---|
|
Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort
|
2 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-7 weeksNumber of subjects who experienced any treatment-emergent adverse events (TEAEs) leading to study drug discontinuation
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 2
n=1 Participants
Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 1b
n=6 Participants
Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 3c
n=13 Participants
Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Leading to Study Drug Discontinuation
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1b
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3c
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1
n=8 participants at risk
Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 2
n=1 participants at risk
Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 1b
n=6 participants at risk
Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 3c
n=13 participants at risk
Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Nervous system disorders
Syncope
|
12.5%
1/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
Other adverse events
| Measure |
Cohort 1
n=8 participants at risk
Donepezil 20mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 2
n=1 participants at risk
Donepezil 20mg/day upward dose titration of 20mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 1b
n=6 participants at risk
Donepezil 10mg/day upward dose titration of 10mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 60mg/day with solifenacin 15 or 20mg/day.
|
Cohort 3c
n=13 participants at risk
Donepezil 10mg/day upward dose titration of 5mg at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) of 40mg/day with solifenacin 15mg/day.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Investigations
Heart rate decreased
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Nervous system disorders
Drooling
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Surgical and medical procedures
Cancer surgery
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
2/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
General disorders
Chills
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
23.1%
3/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
General disorders
Crying
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
General disorders
Feeling jittery
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
100.0%
1/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
33.3%
2/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
15.4%
2/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
15.4%
2/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
15.4%
2/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
23.1%
3/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
23.1%
3/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
33.3%
2/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
16.7%
1/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
15.4%
2/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
15.4%
2/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Eye disorders
Blepharospasm
|
12.5%
1/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/1 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
0.00%
0/6 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
7.7%
1/13 • Adverse events were collected until week 7.
All subjects who received at least one dose of any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER