Trial Outcomes & Findings for ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study) (NCT NCT02136914)
NCT ID: NCT02136914
Last Updated: 2018-02-06
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, 8, 12, 18, and 24.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
126 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2018-02-06
Participant Flow
126 Participants with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were randomized at 41 study sites in the United States and Canada. The first subject was randomized on 20 May 2014 and the last subject completed on 18 November 2015.
All randomized subjects who received ≥ 1 dose of study drug (123) were included in the Safety Analysis Population (60 placebo, 63 ADS-5102); all randomized subjects who received ≥ 1 dose of study drug and provided ≥ 1 postbaseline efficacy assessment (121) were included in the Modified Intent-to-Treat (MITT) population (58 placebo, 63 ADS-5102).
Participant milestones
| Measure |
Placebo
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
ADS-5102 (340 mg)
340 mg dose of ADS-5102 (amantadine hydrochloride \[HCl\] extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
Received Study Drug
|
60
|
63
|
|
Overall Study
COMPLETED
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
ADS-5102 (340 mg)
340 mg dose of ADS-5102 (amantadine hydrochloride \[HCl\] extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Overall Study
Sponsor's Decision to Stop the Study
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
|
Overall Study
Subject Unwilling to Proceed
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Did Not Receive Study Drug
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
ADS-5102 (340 mg)
n=63 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=60 Participants
|
32 Participants
n=63 Participants
|
59 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=60 Participants
|
31 Participants
n=63 Participants
|
64 Participants
n=123 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 8.59 • n=60 Participants
|
63.9 years
STANDARD_DEVIATION 9.43 • n=63 Participants
|
64.7 years
STANDARD_DEVIATION 9.04 • n=123 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=60 Participants
|
28 Participants
n=63 Participants
|
51 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=60 Participants
|
35 Participants
n=63 Participants
|
72 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=60 Participants
|
3 Participants
n=63 Participants
|
12 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=60 Participants
|
60 Participants
n=63 Participants
|
111 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=60 Participants
|
2 Participants
n=63 Participants
|
5 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
1 Participants
n=63 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=60 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=60 Participants
|
60 Participants
n=63 Participants
|
113 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=60 Participants
|
0 Participants
n=63 Participants
|
3 Participants
n=123 Participants
|
|
Unified Dyskinesia Rating Scale (UDysRS)
Total Score
|
38.2 units on a scale
STANDARD_DEVIATION 11.20 • n=60 Participants
|
40.9 units on a scale
STANDARD_DEVIATION 13.34 • n=63 Participants
|
39.6 units on a scale
STANDARD_DEVIATION 12.37 • n=123 Participants
|
|
Unified Dyskinesia Rating Scale (UDysRS)
Total Objective Score (Parts III, IV)
|
15.3 units on a scale
STANDARD_DEVIATION 6.66 • n=60 Participants
|
16.4 units on a scale
STANDARD_DEVIATION 7.72 • n=63 Participants
|
15.9 units on a scale
STANDARD_DEVIATION 7.21 • n=123 Participants
|
|
PD Home Diary
Asleep
|
8.02 hours
STANDARD_DEVIATION 1.446 • n=60 Participants
|
7.78 hours
STANDARD_DEVIATION 1.732 • n=63 Participants
|
7.90 hours
STANDARD_DEVIATION 1.597 • n=123 Participants
|
|
PD Home Diary
Off
|
2.94 hours
STANDARD_DEVIATION 2.105 • n=60 Participants
|
3.16 hours
STANDARD_DEVIATION 2.372 • n=63 Participants
|
3.05 hours
STANDARD_DEVIATION 2.239 • n=123 Participants
|
|
PD Home Diary
ON without Troublesome Dyskinesia
|
8.59 hours
STANDARD_DEVIATION 2.815 • n=60 Participants
|
8.34 hours
STANDARD_DEVIATION 3.466 • n=63 Participants
|
8.46 hours
STANDARD_DEVIATION 3.155 • n=123 Participants
|
|
PD Home Diary
ON with Troublesome Dyskinesia
|
4.46 hours
STANDARD_DEVIATION 1.933 • n=60 Participants
|
4.72 hours
STANDARD_DEVIATION 2.537 • n=63 Participants
|
4.59 hours
STANDARD_DEVIATION 2.257 • n=123 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part I
|
11.5 units on a scale
STANDARD_DEVIATION 4.17 • n=59 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
12.5 units on a scale
STANDARD_DEVIATION 6.18 • n=63 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
12.0 units on a scale
STANDARD_DEVIATION 5.31 • n=122 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part II
|
15.8 units on a scale
STANDARD_DEVIATION 5.80 • n=60 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
15.7 units on a scale
STANDARD_DEVIATION 6.77 • n=63 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
15.8 units on a scale
STANDARD_DEVIATION 6.29 • n=123 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part III
|
24.6 units on a scale
STANDARD_DEVIATION 12.10 • n=60 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
25.9 units on a scale
STANDARD_DEVIATION 14.49 • n=63 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
25.3 units on a scale
STANDARD_DEVIATION 13.34 • n=123 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Combined Parts I, II, and III
|
51.9 units on a scale
STANDARD_DEVIATION 16.95 • n=59 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
54.2 units on a scale
STANDARD_DEVIATION 20.37 • n=63 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
53.1 units on a scale
STANDARD_DEVIATION 18.75 • n=122 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part IV
|
11.3 units on a scale
STANDARD_DEVIATION 2.36 • n=60 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
11.8 units on a scale
STANDARD_DEVIATION 2.95 • n=63 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
11.6 units on a scale
STANDARD_DEVIATION 2.68 • n=123 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part IV, Item 4.1
|
2.4 units on a scale
STANDARD_DEVIATION 0.82 • n=60 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
2.6 units on a scale
STANDARD_DEVIATION 0.94 • n=63 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
2.5 units on a scale
STANDARD_DEVIATION 0.89 • n=123 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Part IV, Item 4.2
|
2.5 units on a scale
STANDARD_DEVIATION 0.54 • n=60 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
2.6 units on a scale
STANDARD_DEVIATION 0.56 • n=63 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
2.5 units on a scale
STANDARD_DEVIATION 0.55 • n=123 Participants • For Part I and combined Parts I, II, and III, in the placebo group, the data is based on 59 patients only.
|
|
Time Since PD Diagnosis
|
8.85 years
STANDARD_DEVIATION 3.911 • n=60 Participants
|
9.45 years
STANDARD_DEVIATION 4.372 • n=63 Participants
|
9.16 years
STANDARD_DEVIATION 4.148 • n=123 Participants
|
|
Duration of Levodopa Treatment
|
6.82 years
STANDARD_DEVIATION 3.346 • n=60 Participants
|
7.82 years
STANDARD_DEVIATION 3.719 • n=63 Participants
|
7.33 years
STANDARD_DEVIATION 3.563 • n=123 Participants
|
|
Duration of LID
|
3.21 years
STANDARD_DEVIATION 2.491 • n=60 Participants
|
4.05 years
STANDARD_DEVIATION 3.085 • n=63 Participants
|
3.64 years
STANDARD_DEVIATION 2.831 • n=123 Participants
|
|
Hoehn and Yahr Stage
|
2.3 units on a scale
STANDARD_DEVIATION 0.56 • n=60 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.54 • n=63 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 0.55 • n=123 Participants
|
|
Subjects taking Antiparkinson Medication
Levodopa (Sinemet or Stalevo)
|
60 Participants
n=60 Participants
|
63 Participants
n=63 Participants
|
123 Participants
n=123 Participants
|
|
Subjects taking Antiparkinson Medication
Dopamine Agonist
|
34 Participants
n=60 Participants
|
29 Participants
n=63 Participants
|
63 Participants
n=123 Participants
|
|
Subjects taking Antiparkinson Medication
MAO Inhibitors
|
24 Participants
n=60 Participants
|
26 Participants
n=63 Participants
|
50 Participants
n=123 Participants
|
|
Subjects taking Antiparkinson Medication
COMT Inhibitor
|
9 Participants
n=60 Participants
|
7 Participants
n=63 Participants
|
16 Participants
n=123 Participants
|
|
Subjects taking Antiparkinson Medication
Anticholinergics
|
3 Participants
n=60 Participants
|
2 Participants
n=63 Participants
|
5 Participants
n=123 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, 8, 12, 18, and 24.
Outcome measures
| Measure |
ADS-5102 (340 mg)
n=63 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
Placebo
n=58 Participants
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12
|
-15.9 units on a scale
Standard Error 1.62
|
-8.0 units on a scale
Standard Error 1.64
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: 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, 8, 12, 18, and 24.
Outcome measures
| Measure |
ADS-5102 (340 mg)
n=63 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
Placebo
n=58 Participants
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24
|
-15.6 units on a scale
Standard Error 1.87
|
-6.3 units on a scale
Standard Error 1.94
|
SECONDARY outcome
Timeframe: Baseline (BL) to Week 12 (W12) and Week 24 (W24)Population: 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, 8, 12, 18, and 24 visits.
Outcome measures
| Measure |
ADS-5102 (340 mg)
n=63 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
Placebo
n=58 Participants
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in ON time w/o troublesome dyskinesia (W12)
|
3.56 hours
Standard Error 0.434
|
0.82 hours
Standard Error 0.432
|
|
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in ON time w/o troublesome dyskinesia (W24)
|
3.59 hours
Standard Error 0.440
|
1.37 hours
Standard Error 0.456
|
|
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in OFF time (W12)
|
-0.59 hours
Standard Error 0.265
|
0.32 hours
Standard Error 0.263
|
|
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in OFF time (W24)
|
-0.58 hours
Standard Error 0.268
|
0.22 hours
Standard Error 0.282
|
|
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in ON time w/ troublesome dyskinesia (W12)
|
-3.12 hours
Standard Error 0.359
|
-1.58 hours
Standard Error 0.358
|
|
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Change in ON time w/ troublesome dyskinesia (W24)
|
-3.31 hours
Standard Error 0.363
|
-1.86 hours
Standard Error 0.380
|
SECONDARY outcome
Timeframe: Baseline (BL) to Week 12 (W12) and Week 24 (W24)Population: MITT population
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each Part contains items or questions that were each rated on a scale from 0 (normal) to 4 (severe). The Combined Parts I, II, and III (representing the sum of the individual scores from Parts I, II, and III) has a scale range of 0-236. Higher scores, whether for individual Parts or the sum of the combined Parts, indicate more severe PD.
Outcome measures
| Measure |
ADS-5102 (340 mg)
n=63 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
Placebo
n=58 Participants
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)
Change from BL at Week 12
|
-5.2 units on a scale
Standard Error 1.92
|
-4.0 units on a scale
Standard Error 1.96
|
|
Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)
Change from BL at Week 24
|
-1.3 units on a scale
Standard Error 2.45
|
-3.5 units on a scale
Standard Error 2.60
|
SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 24Population: MITT population
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement). The CGI-C was assessed at Baseline and Weeks 2, 8, 12, 18, and 24.
Outcome measures
| Measure |
ADS-5102 (340 mg)
n=63 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
Placebo
n=58 Participants
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 12 · Marked Improvement
|
18 Participants
|
2 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 12 · Moderate Improvement
|
20 Participants
|
9 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 12 · Minimal Improvement
|
13 Participants
|
10 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 12 · No Change
|
9 Participants
|
25 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 12 · Minimal Worsening
|
2 Participants
|
10 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 12 · Moderate Worsening
|
0 Participants
|
2 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 24 · Marked Improvement
|
14 Participants
|
5 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 24 · Minimal Improvement
|
12 Participants
|
12 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 24 · No Change
|
7 Participants
|
17 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 24 · Minimal Worsening
|
5 Participants
|
6 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 24 · Moderate Worsening
|
5 Participants
|
4 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 24 · Marked Worsening
|
2 Participants
|
0 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 12 · Marked Worsening
|
1 Participants
|
0 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Week 24 · Moderate Improvement
|
17 Participants
|
10 Participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
ADS-5102 (340 mg)
Serious events: 7 serious events
Other events: 56 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=60 participants at risk
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
ADS-5102 (340 mg)
n=63 participants at risk
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.3%
2/60 • Number of events 2 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Infections and infestations
Cellulitis
|
1.7%
1/60 • Number of events 1 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/60 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Nervous system disorders
Presyncope
|
0.00%
0/60 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/60 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/60 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/60 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/60 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Nervous system disorders
ON and OFF phenomenon
|
0.00%
0/60 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/60 • Baseline through Week 25
|
1.6%
1/63 • Number of events 1 • Baseline through Week 25
|
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
|
ADS-5102 (340 mg)
n=63 participants at risk
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
|
|---|---|---|
|
Psychiatric disorders
Hallucination, any type
|
1.7%
1/60 • Baseline through Week 25
|
28.6%
18/63 • Baseline through Week 25
|
|
Psychiatric disorders
Hallucination, visual
|
1.7%
1/60 • Baseline through Week 25
|
23.8%
15/63 • Baseline through Week 25
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/60 • Baseline through Week 25
|
7.9%
5/63 • Baseline through Week 25
|
|
General disorders
Oedema peripheral
|
0.00%
0/60 • Baseline through Week 25
|
23.8%
15/63 • Baseline through Week 25
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60 • Baseline through Week 25
|
22.2%
14/63 • Baseline through Week 25
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/60 • Baseline through Week 25
|
17.5%
11/63 • Baseline through Week 25
|
|
Gastrointestinal disorders
Constipation
|
5.0%
3/60 • Baseline through Week 25
|
14.3%
9/63 • Baseline through Week 25
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
5/60 • Baseline through Week 25
|
15.9%
10/63 • Baseline through Week 25
|
|
Infections and infestations
Urinary tract infection
|
8.3%
5/60 • Baseline through Week 25
|
11.1%
7/63 • Baseline through Week 25
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/60 • Baseline through Week 25
|
9.5%
6/63 • Baseline through Week 25
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/60 • Baseline through Week 25
|
9.5%
6/63 • Baseline through Week 25
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/60 • Baseline through Week 25
|
9.5%
6/63 • Baseline through Week 25
|
|
Psychiatric disorders
Abnormal dreams
|
3.3%
2/60 • Baseline through Week 25
|
6.3%
4/63 • Baseline through Week 25
|
|
Psychiatric disorders
Depression
|
1.7%
1/60 • Baseline through Week 25
|
6.3%
4/63 • Baseline through Week 25
|
|
Nervous system disorders
Headache
|
3.3%
2/60 • Baseline through Week 25
|
6.3%
4/63 • Baseline through Week 25
|
|
Nervous system disorders
Balance disorder
|
5.0%
3/60 • Baseline through Week 25
|
3.2%
2/63 • Baseline through Week 25
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
3/60 • Baseline through Week 25
|
1.6%
1/63 • Baseline through Week 25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
4/60 • Baseline through Week 25
|
4.8%
3/63 • Baseline through Week 25
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
3/60 • Baseline through Week 25
|
1.6%
1/63 • Baseline through Week 25
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
3/60 • Baseline through Week 25
|
0.00%
0/63 • Baseline through Week 25
|
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