Trial · NCT02153645

Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.

NCT02153645, Phase 3, Terminated, Adamas Pharmaceuticals, Inc.; results first posted 2019-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. Trials, record NCT02153645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02153645

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.
NCT number: NCT02153645
Status: Terminated
Phases: Phase 3
Enrollment: 87 participants, actual
Lead sponsor: Adamas Pharmaceuticals, Inc.
Conditions: Parkinson's Disease, Levodopa Induced Dyskinesias (LID)
Interventions: 240mg Amantadine HCl ER tablets, Placebo tablets, 320mg Amantadine HCl ER tablets
First posted: 2014-06-03
Last updated: 2022-02-16
Results first posted: 2019-04-02

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Unified Dyskinesia Rating Scale	From baseline to Day 98	The Unified Dyskinesia Rating Scale is a validated tool for assessment of dyskinesia (involuntary movements) in Parkinson's Disease patients. Rating consists of the change from baseline to Day 98 of the sum of the 26 questions comprising the questionnaire. Each question in the questionnaire is rated on a 5 point scale from 0-4 where 0 is a better outcome. Questions assess: over the past week total hours with dyskinesia and total hours without dyskinesia; problems with speech, chewing and swallowing, eating, dressing, hygiene, handwriting, hobbies, balance, socializing, emotions, spasm or cramps, pain without dystonia (spasm or cramps) and pain from dystonia, the degree of impairment for each of 7 body parts, and the degree of disability in communication, drinking from a cup, dressing and ambulation. The minimum score is 0 (better) and the maximum score is 130 (worse).
Secondary	Mobility State Self-Assessment - Subject Diary Cards	Day 14 and Day 98 of treatment	Change from baseline in the number of awake hours without troublesome dyskinesia (involuntary movements). Every half hour the subject will indicate in the diary if the medication has ("ON") or has not ("OFF") produced benefits in terms of mobility, slowness and rigidity. Valid diaries of the 3 consecutive days prior to each visit will be averaged with respect to the number of awake hours without troublesome dyskinesia. The change from baseline in the number of waking hours that subjects report being "ON" without troublesome dyskinesias will be analyzed at analysis visits Day 14 and Day 98 of treatment. Higher scores mean a better outcome and the maximum value is 24 hours.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Unified Dyskinesia Rating Scale	From baseline to Day 98		score on a scale	MEAN
SECONDARY	Mobility State Self-Assessment - Subject Diary Cards	Day 14 and Day 98 of treatment	The number analyzed was the number of subjects with values at each time point.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Unified Dyskinesia Rating Scale	240 mg Amantadine HCl ER Tablets	Visit 2 (Baseline)	46.2	Standard Deviation 13.19	score on a scale
Unified Dyskinesia Rating Scale	320 mg Amantadine HCl ER Tablets	Visit 2 (Baseline)	39.2	Standard Deviation 11.91	score on a scale
Unified Dyskinesia Rating Scale	Placebo Amantadine HCl ER Tablets	Visit 2 (Baseline)	38.7	Standard Deviation 11.23	score on a scale
Unified Dyskinesia Rating Scale	240 mg Amantadine HCl ER Tablets	Visit 7 (Day 98)/Stable Dose LOCF [1]	27.5	Standard Deviation 19.13	score on a scale
Unified Dyskinesia Rating Scale	320 mg Amantadine HCl ER Tablets	Visit 7 (Day 98)/Stable Dose LOCF [1]	26.4	Standard Deviation 13.17	score on a scale
Unified Dyskinesia Rating Scale	Placebo Amantadine HCl ER Tablets	Visit 7 (Day 98)/Stable Dose LOCF [1]	28.7	Standard Deviation 13.70	score on a scale
Unified Dyskinesia Rating Scale	240 mg Amantadine HCl ER Tablets	Change from Baseline (SD)	-18.8	Standard Deviation 16.38	score on a scale
Unified Dyskinesia Rating Scale	320 mg Amantadine HCl ER Tablets	Change from Baseline (SD)	-13.3	Standard Deviation 13.73	score on a scale
Unified Dyskinesia Rating Scale	Placebo Amantadine HCl ER Tablets	Change from Baseline (SD)	-9.6	Standard Deviation 14.87	score on a scale
Mobility State Self-Assessment - Subject Diary Cards	240 mg Amantadine HCl ER Tablets	Visit 2 (Baseline)	3.5	Standard Deviation 2.02	score on a scale

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	240mg Amantadine Hydrochloride (HCl) ER Tablets	30
Overall Study	STARTED	320mg Amantadine HCl ER Tablets	29
Overall Study	STARTED	Placebo Tablets for Amantadine	28
Overall Study	COMPLETED	240mg Amantadine Hydrochloride (HCl) ER Tablets	17
Overall Study	COMPLETED	320mg Amantadine HCl ER Tablets	19
Overall Study	COMPLETED	Placebo Tablets for Amantadine	18
Overall Study	NOT COMPLETED	240mg Amantadine Hydrochloride (HCl) ER Tablets	13
Overall Study	NOT COMPLETED	320mg Amantadine HCl ER Tablets	10
Overall Study	NOT COMPLETED	Placebo Tablets for Amantadine	10

Source ClinicalTrials.gov

Adverse events351

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	240mg Amantadine HCl ER Tablets	1	30	1
other	Anaemia	Blood and lymphatic system disorders	320mg Amantadine HCl ER Tablets	0	29	0
other	Anaemia	Blood and lymphatic system disorders	Placebo Tablets for Amantadine	0	28	0
other	Angina pectoris	Cardiac disorders	240mg Amantadine HCl ER Tablets	0	30	0
other	Angina pectoris	Cardiac disorders	320mg Amantadine HCl ER Tablets	0	29	0
other	Angina pectoris	Cardiac disorders	Placebo Tablets for Amantadine	1	28	1
other	Arrhythmia supraventricular	Cardiac disorders	240mg Amantadine HCl ER Tablets	0	30	0
other	Arrhythmia supraventricular	Cardiac disorders	320mg Amantadine HCl ER Tablets	0	29	0
other	Arrhythmia supraventricular	Cardiac disorders	Placebo Tablets for Amantadine	1	28	1
other	Extrasystoles	Cardiac disorders	240mg Amantadine HCl ER Tablets	1	30	1

1 to 10 of 351Source ClinicalTrials.gov

See all 351 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	240mg Amantadine HCl ER Tablets	1	30
Total, all-cause mortality	320mg Amantadine HCl ER Tablets	0	29
Total, all-cause mortality	Placebo Tablets for Amantadine	0	28
Total, other adverse events	240mg Amantadine HCl ER Tablets	20	30
Total, other adverse events	320mg Amantadine HCl ER Tablets	24	29
Total, other adverse events	Placebo Tablets for Amantadine	15	28
Total, serious adverse events	240mg Amantadine HCl ER Tablets	3	30
Total, serious adverse events	320mg Amantadine HCl ER Tablets	1	29
Total, serious adverse events	Placebo Tablets for Amantadine	2	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02153645

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API reference For AI assistants