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ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study) (EASE LID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02136914
Recruitment Status : Completed
First Posted : May 13, 2014
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dyskinesia
Levodopa Induced Dyskinesia (LID)
Parkinson's Disease
Interventions Drug: ADS-5102
Other: Placebo
Enrollment 126
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Placebo ADS-5102 (340 mg)
Hide Arm/Group Description Placebo: oral capsules administered once nightly at bedtime for 25 weeks 340 mg dose of ADS-5102 (amantadine hydrochloride [HCl] extended release): oral capsules administered once nightly at bedtime for 25 weeks
Period Title: Overall Study
Started 63 63
Received Study Drug 60 63
Completed 42 42
Not Completed 21 21
Reason Not Completed
Sponsor's Decision to Stop the Study             7             7
Withdrawal by Subject             3             10
Subject Unwilling to Proceed             7             2
Lost to Follow-up             1             1
Did Not Receive Study Drug             2             0
Lack of Efficacy             1             0
Death             0             1
Arm/Group Title Placebo ADS-5102 (340 mg) Total
Hide Arm/Group Description Placebo: oral capsules administered once nightly at bedtime for 25 weeks 340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks Total of all reporting groups
Overall Number of Baseline Participants 60 63 123
Hide Baseline Analysis Population Description
Safety Analysis Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 63 participants 123 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
  45.0%
32
  50.8%
59
  48.0%
>=65 years
33
  55.0%
31
  49.2%
64
  52.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 63 participants 123 participants
65.6  (8.59) 63.9  (9.43) 64.7  (9.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 63 participants 123 participants
Female
23
  38.3%
28
  44.4%
51
  41.5%
Male
37
  61.7%
35
  55.6%
72
  58.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 63 participants 123 participants
Hispanic or Latino
9
  15.0%
3
   4.8%
12
   9.8%
Not Hispanic or Latino
51
  85.0%
60
  95.2%
111
  90.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 63 participants 123 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   5.0%
2
   3.2%
5
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.6%
1
   0.8%
Black or African American
1
   1.7%
0
   0.0%
1
   0.8%
White
53
  88.3%
60
  95.2%
113
  91.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   5.0%
0
   0.0%
3
   2.4%
Unified Dyskinesia Rating Scale (UDysRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Total Score Number Analyzed 60 participants 63 participants 123 participants
38.2  (11.20) 40.9  (13.34) 39.6  (12.37)
Total Objective Score (Parts III, IV) Number Analyzed 60 participants 63 participants 123 participants
15.3  (6.66) 16.4  (7.72) 15.9  (7.21)
[1]
Measure Description: The UDysRS is a dyskinesia rating scale that evaluates involuntary movements associated with PD; the UDysRS consists of the following sub-parts: IA, IB, IIA, IIB, III, and IV. The total score is the sum of all individual sub-parts, and scores for this measure can range from 0-104. The total objective score is the sum of Part III (which measures objective impairment) and Part IV (which measures objective disability), and scores for this measure can range from 0-44. For both the total score and total objective score, a higher score indicates more severe PD.
PD Home Diary   [1] 
Mean (Standard Deviation)
Unit of measure:  Hours
Asleep Number Analyzed 60 participants 63 participants 123 participants
8.02  (1.446) 7.78  (1.732) 7.90  (1.597)
Off Number Analyzed 60 participants 63 participants 123 participants
2.94  (2.105) 3.16  (2.372) 3.05  (2.239)
ON without Troublesome Dyskinesia Number Analyzed 60 participants 63 participants 123 participants
8.59  (2.815) 8.34  (3.466) 8.46  (3.155)
ON with Troublesome Dyskinesia Number Analyzed 60 participants 63 participants 123 participants
4.46  (1.933) 4.72  (2.537) 4.59  (2.257)
[1]
Measure Description: 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.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Part I Number Analyzed 59 participants 63 participants 122 participants
11.5  (4.17) 12.5  (6.18) 12.0  (5.31)
Part II Number Analyzed 60 participants 63 participants 123 participants
15.8  (5.80) 15.7  (6.77) 15.8  (6.29)
Part III Number Analyzed 60 participants 63 participants 123 participants
24.6  (12.10) 25.9  (14.49) 25.3  (13.34)
Combined Parts I, II, and III Number Analyzed 59 participants 63 participants 122 participants
51.9  (16.95) 54.2  (20.37) 53.1  (18.75)
Part IV Number Analyzed 60 participants 63 participants 123 participants
11.3  (2.36) 11.8  (2.95) 11.6  (2.68)
Part IV, Item 4.1 Number Analyzed 60 participants 63 participants 123 participants
2.4  (0.82) 2.6  (0.94) 2.5  (0.89)
Part IV, Item 4.2 Number Analyzed 60 participants 63 participants 123 participants
2.5  (0.54) 2.6  (0.56) 2.5  (0.55)
[1]
Measure Description: The MDS-UPDRS Parts I, II, III, and IV examined non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications, respectively. Each Part contains items/questions, each rated on a scale from 0 (normal) to 4 (severe). The range of total scores for each Part is as follows: Part I, 0-52; Part II, 0-52; Part III, 0-132; Part IV, 0-24. Combined Parts I, II, and III is the sum of scores from Parts I, II, and III and has a scale range of 0-236. Parts 4.1 and 4.2 each has a scale range of 0-4. Higher scores indicate more severe PD.
[2]
Measure Analysis Population Description: 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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 63 participants 123 participants
8.85  (3.911) 9.45  (4.372) 9.16  (4.148)
Duration of Levodopa Treatment  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 63 participants 123 participants
6.82  (3.346) 7.82  (3.719) 7.33  (3.563)
Duration of LID  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 63 participants 123 participants
3.21  (2.491) 4.05  (3.085) 3.64  (2.831)
Hoehn and Yahr Stage   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 60 participants 63 participants 123 participants
2.3  (0.56) 2.2  (0.54) 2.3  (0.55)
[1]
Measure Description: The Hoehn and Yahr scale, from 1-5, describes the patient's PD progression. The higher the score the more severe the symptoms of PD.
Subjects taking Antiparkinson Medication   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Levodopa (Sinemet or Stalevo) Number Analyzed 60 participants 63 participants 123 participants
60
 100.0%
63
 100.0%
123
 100.0%
Dopamine Agonist Number Analyzed 60 participants 63 participants 123 participants
34
  56.7%
29
  46.0%
63
  51.2%
MAO Inhibitors Number Analyzed 60 participants 63 participants 123 participants
24
  40.0%
26
  41.3%
50
  40.7%
COMT Inhibitor Number Analyzed 60 participants 63 participants 123 participants
9
  15.0%
7
  11.1%
16
  13.0%
Anticholinergics Number Analyzed 60 participants 63 participants 123 participants
3
   5.0%
2
   3.2%
5
   4.1%
[1]
Measure Description: Patients may have been taking more than 1 antiparkinson medication at Baseline
1.Primary Outcome
Title Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Placebo ADS-5102 (340 mg)
Hide Arm/Group Description:
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
Overall Number of Participants Analyzed 58 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.0  (1.64) -15.9  (1.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments 46 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Linear Mixed Model w/ Repeated Measures
Comments Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.9
Confidence Interval (2-Sided) 95%
-12.5 to -3.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.30
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24
Hide Description 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.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Placebo ADS-5102 (340 mg)
Hide Arm/Group Description:
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
Overall Number of Participants Analyzed 58 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.3  (1.94) -15.6  (1.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.3
Confidence Interval (2-Sided) 95%
-14.7 to -4.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.70
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Hide Description 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.
Time Frame Baseline (BL) to Week 12 (W12) and Week 24 (W24)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Placebo ADS-5102 (340 mg)
Hide Arm/Group Description:
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
Overall Number of Participants Analyzed 58 63
Least Squares Mean (Standard Error)
Unit of Measure: hours
Change in ON time w/o troublesome dyskinesia (W12) 0.82  (0.432) 3.56  (0.434)
Change in ON time w/o troublesome dyskinesia (W24) 1.37  (0.456) 3.59  (0.440)
Change in OFF time (W12) 0.32  (0.263) -0.59  (0.265)
Change in OFF time (W24) 0.22  (0.282) -0.58  (0.268)
Change in ON time w/ troublesome dyskinesia (W12) -1.58  (0.358) -3.12  (0.359)
Change in ON time w/ troublesome dyskinesia (W24) -1.86  (0.380) -3.31  (0.363)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change from Baseline in ON time without troublesome dyskinesia at Week 12.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.74
Confidence Interval (2-Sided) 95%
1.53 to 3.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.612
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments Change from Baseline in ON time without troublesome dyskinesia at Week 24.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
0.96 to 3.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.634
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0171
Comments Change from Baseline in OFF time at Week 12.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-1.64 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.373
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0406
Comments Change from Baseline in OFF time at Week 24.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.58 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.389
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments Change from Baseline in ON time with troublesome dyskinesia at Week 12.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.54
Confidence Interval (2-Sided) 95%
-2.55 to -0.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.508
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0072
Comments Change from Baseline in ON time with troublesome dyskinesia at Week 24.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.45
Confidence Interval (2-Sided) 95%
-2.49 to -0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.526
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)
Hide Description 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.
Time Frame Baseline (BL) to Week 12 (W12) and Week 24 (W24)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Placebo ADS-5102 (340 mg)
Hide Arm/Group Description:
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
Overall Number of Participants Analyzed 58 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change from BL at Week 12 -4.0  (1.96) -5.2  (1.92)
Change from BL at Week 24 -3.5  (2.60) -1.3  (2.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6833
Comments Change from Baseline in MDS-UPDRS at Week 12.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-6.6 to 4.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5557
Comments Change from Baseline in MDS-UPDRS at Week 24.
Method Linear Mixed Model w/ Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-5.0 to 9.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.58
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Hide Description 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.
Time Frame Baseline to Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Placebo ADS-5102 (340 mg)
Hide Arm/Group Description:
Placebo: oral capsules administered once nightly at bedtime for 25 weeks
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
Overall Number of Participants Analyzed 58 63
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12 Number Analyzed 58 participants 63 participants
Marked Improvement
2
   3.4%
18
  28.6%
Moderate Improvement
9
  15.5%
20
  31.7%
Minimal Improvement
10
  17.2%
13
  20.6%
No Change
25
  43.1%
9
  14.3%
Minimal Worsening
10
  17.2%
2
   3.2%
Moderate Worsening
2
   3.4%
0
   0.0%
Marked Worsening
0
   0.0%
1
   1.6%
Week 24 Number Analyzed 54 participants 62 participants
Marked Improvement
5
   9.3%
14
  22.6%
Moderate Improvement
10
  18.5%
17
  27.4%
Minimal Improvement
12
  22.2%
12
  19.4%
No Change
17
  31.5%
7
  11.3%
Minimal Worsening
6
  11.1%
5
   8.1%
Moderate Worsening
4
   7.4%
5
   8.1%
Marked Worsening
0
   0.0%
2
   3.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Baseline to Week 12
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ADS-5102 (340 mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1071
Comments Baseline to Week 24
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame Baseline through Week 25
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo ADS-5102 (340 mg)
Hide Arm/Group Description Placebo: oral capsules administered once nightly at bedtime for 25 weeks 340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once nightly at bedtime for 25 weeks
All-Cause Mortality
Placebo ADS-5102 (340 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)      1/63 (1.59%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo ADS-5102 (340 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/60 (5.00%)      7/63 (11.11%)    
Gastrointestinal disorders     
Small intestinal obstruction  1  0/60 (0.00%)  0 1/63 (1.59%)  1
Constipation  1  0/60 (0.00%)  0 1/63 (1.59%)  1
Infections and infestations     
Cellulitis  1  1/60 (1.67%)  1 1/63 (1.59%)  1
Injury, poisoning and procedural complications     
Hip fracture  1  2/60 (3.33%)  2 1/63 (1.59%)  1
Humerus fracture  1  0/60 (0.00%)  0 1/63 (1.59%)  1
Subdural haematoma  1  0/60 (0.00%)  0 1/63 (1.59%)  1
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  0/60 (0.00%)  0 1/63 (1.59%)  1
Nervous system disorders     
Presyncope  1  0/60 (0.00%)  0 1/63 (1.59%)  1
ON and OFF phenomenon  1  0/60 (0.00%)  0 1/63 (1.59%)  1
Encephalopathy  1  0/60 (0.00%)  0 1/63 (1.59%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo ADS-5102 (340 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/60 (60.00%)      56/63 (88.89%)    
Gastrointestinal disorders     
Dry mouth  1  0/60 (0.00%)  11/63 (17.46%) 
Constipation  1  3/60 (5.00%)  9/63 (14.29%) 
General disorders     
Oedema peripheral  1  0/60 (0.00%)  15/63 (23.81%) 
Infections and infestations     
Urinary tract infection  1  5/60 (8.33%)  7/63 (11.11%) 
Nasopharyngitis  1  3/60 (5.00%)  1/63 (1.59%) 
Injury, poisoning and procedural complications     
Fall  1  5/60 (8.33%)  10/63 (15.87%) 
Contusion  1  1/60 (1.67%)  6/63 (9.52%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/60 (6.67%)  3/63 (4.76%) 
Musculoskeletal pain  1  3/60 (5.00%)  1/63 (1.59%) 
Arthralgia  1  3/60 (5.00%)  0/63 (0.00%) 
Nervous system disorders     
Dizziness  1  0/60 (0.00%)  14/63 (22.22%) 
Headache  1  2/60 (3.33%)  4/63 (6.35%) 
Balance disorder  1  3/60 (5.00%)  2/63 (3.17%) 
Psychiatric disorders     
Hallucination, any type  1  1/60 (1.67%)  18/63 (28.57%) 
Hallucination, visual  1  1/60 (1.67%)  15/63 (23.81%) 
Hallucination, auditory  1  0/60 (0.00%)  5/63 (7.94%) 
Anxiety  1  1/60 (1.67%)  6/63 (9.52%) 
Abnormal dreams  1  2/60 (3.33%)  4/63 (6.35%) 
Depression  1  1/60 (1.67%)  4/63 (6.35%) 
Skin and subcutaneous tissue disorders     
Livedo reticularis  1  0/60 (0.00%)  6/63 (9.52%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Head, Regulatory Affairs
Organization: Adamas Pharmaceuticals, Inc.
Phone: +1 (510) 450-3500
Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02136914     History of Changes
Other Study ID Numbers: ADS-AMT-PD301
First Submitted: May 9, 2014
First Posted: May 13, 2014
Results First Submitted: September 21, 2017
Results First Posted: February 6, 2018
Last Update Posted: February 6, 2018