Trial Outcomes & Findings for Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia (NCT NCT02274766)
NCT ID: NCT02274766
Last Updated: 2018-01-10
Results Overview
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2018-01-10
Participant Flow
77 subjects with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were randomized at 32 study sites in the United States, Germany, France, Spain, and Austria. The first subject was randomized on 23 October 2014 and the last subject completed on 10 March 2016.
All randomized subjects who received ≥ 1 dose of study drug and provided ≥ 1 postbaseline efficacy assessment (75) were included in both the Safety Analysis Population and the Modified Intent-to-Treat (MITT) population (with 38 subjects in the placebo group and 37 in the ADS-5102 group).
Participant milestones
| Measure |
Placebo
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
|
ADS-5102 (Amantadine HCl Extended Release)
340 mg dose of ADS-5102 (amantadine hydrochloride \[HCl\] extended release): oral capsules administered once nightly at bedtime for 13 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
|
Overall Study
Received Study Drug
|
38
|
37
|
|
Overall Study
COMPLETED
|
35
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
|
ADS-5102 (Amantadine HCl Extended Release)
340 mg dose of ADS-5102 (amantadine hydrochloride \[HCl\] extended release): oral capsules administered once nightly at bedtime for 13 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Did Not Receive Study Drug
|
1
|
1
|
|
Overall Study
Subject Unwilling to Proceed
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
|
ADS-5102 (Amantadine HCl Extended Release)
n=37 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 9.66 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 9.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Unified Dyskinesia Rating Scale (UDysRS)
Total Score
|
41.2 units on a scale
STANDARD_DEVIATION 10.32 • n=5 Participants
|
40.2 units on a scale
STANDARD_DEVIATION 13.06 • n=7 Participants
|
40.7 units on a scale
STANDARD_DEVIATION 11.68 • n=5 Participants
|
|
Unified Dyskinesia Rating Scale (UDysRS)
Total Objective Score (Parts III, IV)
|
15.9 units on a scale
STANDARD_DEVIATION 7.00 • n=5 Participants
|
18.1 units on a scale
STANDARD_DEVIATION 7.99 • n=7 Participants
|
17.0 units on a scale
STANDARD_DEVIATION 7.53 • n=5 Participants
|
|
PD Home Diary
ON time without troublesome dyskinesia
|
7.79 hours
STANDARD_DEVIATION 3.249 • n=5 Participants
|
8.77 hours
STANDARD_DEVIATION 2.457 • n=7 Participants
|
8.27 hours
STANDARD_DEVIATION 2.909 • n=5 Participants
|
|
PD Home Diary
ON time with troublesome dyskinesia
|
6.02 hours
STANDARD_DEVIATION 3.353 • n=5 Participants
|
4.71 hours
STANDARD_DEVIATION 2.509 • n=7 Participants
|
5.37 hours
STANDARD_DEVIATION 3.020 • n=5 Participants
|
|
PD Home Diary
OFF time
|
1.98 hours
STANDARD_DEVIATION 1.687 • n=5 Participants
|
2.62 hours
STANDARD_DEVIATION 2.015 • n=7 Participants
|
2.30 hours
STANDARD_DEVIATION 1.871 • n=5 Participants
|
|
PD Home Diary
Asleep time
|
8.21 hours
STANDARD_DEVIATION 1.643 • n=5 Participants
|
7.91 hours
STANDARD_DEVIATION 1.502 • n=7 Participants
|
8.06 hours
STANDARD_DEVIATION 1.572 • n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part I
|
9.9 units on a scale
STANDARD_DEVIATION 4.86 • n=5 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 5.87 • n=7 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 5.39 • n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part II
|
14.8 units on a scale
STANDARD_DEVIATION 6.06 • n=5 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 6.15 • n=7 Participants
|
14.4 units on a scale
STANDARD_DEVIATION 6.07 • n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part III
|
21.4 units on a scale
STANDARD_DEVIATION 10.22 • n=5 Participants
|
21.2 units on a scale
STANDARD_DEVIATION 9.24 • n=7 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 9.68 • n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Combined Parts I, II, and III
|
46.1 units on a scale
STANDARD_DEVIATION 17.00 • n=5 Participants
|
46.6 units on a scale
STANDARD_DEVIATION 14.76 • n=7 Participants
|
46.3 units on a scale
STANDARD_DEVIATION 15.83 • n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part IV
|
11.1 units on a scale
STANDARD_DEVIATION 2.40 • n=5 Participants
|
9.8 units on a scale
STANDARD_DEVIATION 2.78 • n=7 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 2.66 • n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part IV, Item 4.1
|
2.8 units on a scale
STANDARD_DEVIATION 0.94 • n=5 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.81 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.92 • n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part IV, Item 4.2
|
2.5 units on a scale
STANDARD_DEVIATION 0.51 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.61 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.55 • n=5 Participants
|
|
Time Since PD Diagnosis
|
10.71 years
STANDARD_DEVIATION 4.265 • n=5 Participants
|
10.40 years
STANDARD_DEVIATION 5.105 • n=7 Participants
|
10.55 years
STANDARD_DEVIATION 4.669 • n=5 Participants
|
|
Duration of Levodopa Treatment
|
8.54 years
STANDARD_DEVIATION 4.845 • n=5 Participants
|
7.69 years
STANDARD_DEVIATION 4.121 • n=7 Participants
|
8.12 years
STANDARD_DEVIATION 4.493 • n=5 Participants
|
|
Duration of LID
|
3.98 years
STANDARD_DEVIATION 2.566 • n=5 Participants
|
3.78 years
STANDARD_DEVIATION 3.160 • n=7 Participants
|
3.88 years
STANDARD_DEVIATION 2.857 • n=5 Participants
|
|
Hoehn and Yahr Stage
|
2.4 units on a scale
STANDARD_DEVIATION 0.55 • n=5 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
|
|
Subjects taking Antiparkinson Medication
Levodopa
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Subjects taking Antiparkinson Medication
Dopamine Agonists
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Subjects taking Antiparkinson Medication
MAO Inhibitors
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Subjects taking Antiparkinson Medication
COMT Inhibitors
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Subjects taking Antiparkinson Medication
Anticholinergics
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: MITT population
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
|
ADS-5102 (Amantadine HCl Extended Release)
n=37 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
|
|---|---|---|
|
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score
|
-6.3 units on a scale
Standard Error 2.08
|
-20.7 units on a scale
Standard Error 2.20
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: MITT population
A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 4, 8, and 12 visits.
Outcome measures
| Measure |
Placebo
n=38 Participants
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
|
ADS-5102 (Amantadine HCl Extended Release)
n=37 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
|
|---|---|---|
|
Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in ON time without troublesome dyskinesia
|
2.05 hours
Standard Error 0.526
|
3.95 hours
Standard Error 0.562
|
|
Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in ON time with troublesome dyskinesia
|
-2.47 hours
Standard Error 0.436
|
-3.61 hours
Standard Error 0.468
|
|
Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in OFF time
|
0.61 hours
Standard Error 0.313
|
-0.49 hours
Standard Error 0.336
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
ADS-5102 (Amantadine HCl Extended Release)
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=38 participants at risk
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
|
ADS-5102 (Amantadine HCl Extended Release)
n=37 participants at risk
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
Other adverse events
| Measure |
Placebo
n=38 participants at risk
Placebo: oral capsules administered once nightly at bedtime for 13 weeks
|
ADS-5102 (Amantadine HCl Extended Release)
n=37 participants at risk
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 13 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
1/38 • Baseline through Week 13
|
13.5%
5/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Baseline through Week 13
|
13.5%
5/37 • Baseline through Week 13
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/38 • Baseline through Week 13
|
10.8%
4/37 • Baseline through Week 13
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/38 • Baseline through Week 13
|
10.8%
4/37 • Baseline through Week 13
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/38 • Baseline through Week 13
|
10.8%
4/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
2/38 • Baseline through Week 13
|
8.1%
3/37 • Baseline through Week 13
|
|
Psychiatric disorders
Hallucination (Pooled)
|
5.3%
2/38 • Baseline through Week 13
|
8.1%
3/37 • Baseline through Week 13
|
|
Psychiatric disorders
Apathy
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Nervous system disorders
Dizziness
|
2.6%
1/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Nervous system disorders
Dystonia
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
General disorders
Malaise
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Nervous system disorders
Somnolence
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
2/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
General disorders
Asthenia
|
5.3%
2/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
3/38 • Baseline through Week 13
|
5.4%
2/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Gastrointestinal disorders
Toothache
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Psychiatric disorders
Confusional state
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Psychiatric disorders
Restlessness
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Nervous system disorders
Freezing phenomenon
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Nervous system disorders
Transverse sinus thrombosis
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Nervous system disorders
Disturbance in attention
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Nervous system disorders
Tremor
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
General disorders
Gait disturbance
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
General disorders
Pain
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
General disorders
Hunger
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
General disorders
Oedema peripheral
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Injury, poisoning and procedural complications
Injury
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Infections and infestations
Influenza
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Infections and infestations
Bronchitis
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Renal and urinary disorders
Nocturia
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Renal and urinary disorders
Renal cyst
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Renal and urinary disorders
Urinary incontinence
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Cardiac disorders
Palpitations
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Eye disorders
Cataract
|
2.6%
1/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Eye disorders
Photophobia
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Eye disorders
Vision blurred
|
2.6%
1/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Eye disorders
Vitreous floaters
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Eye disorders
Visual impairement
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Investigations
Weight increased
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Investigations
Glomerular filtration rate decreased
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.6%
1/38 • Baseline through Week 13
|
0.00%
0/37 • Baseline through Week 13
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
1/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/38 • Baseline through Week 13
|
2.7%
1/37 • Baseline through Week 13
|
Additional Information
Head, Regulatory Affairs
Adamas Pharmaceuticals, Inc.
Phone: +1 (510) 450-3500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place