Trial · NCT01397422
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
NCT01397422, Phase 2, Phase 3, Completed, Adamas Pharmaceuticals, Inc.; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study). Trials, record NCT01397422. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01397422
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
- NCT number
- NCT01397422
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 83 participants, actual
- Lead sponsor
- Adamas Pharmaceuticals, Inc.
- Conditions
- Dyskinesia, Levodopa Induced Dyskinesia, Parkinson's Disease
- Interventions
- ADS-5102 (extended release amantadine HCl)
- First posted
- 2011-07-19
- Last updated
- 2017-12-13
- Results first posted
- 2017-11-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | Baseline (Day 1) and Week 8 | The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received. |
| Secondary | Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | Baseline (Day 1) and Week 8 | The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity. |
| Secondary | Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | Baseline (Day 1) and Week 8 | UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia. |
| Secondary | Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary | Baseline (Day 1) and Week 8 | A PD home diary was used to score 5 different conditions in 30-minute time 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 8 visit. |
| Secondary | Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 | Baseline (Day 1) and Week 8 | 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 had sub scales ranging from normal = 0 to severe = 4. |
| Secondary | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Baseline (Day 1) and Week 8 | 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). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | Baseline (Day 1) and Week 8 | Participants in the MITT population with available data were analyzed. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | Baseline (Day 1) and Week 8 | MITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | Baseline (Day 1) and Week 8 | MITT Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary | Baseline (Day 1) and Week 8 | MITT population | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 | Baseline (Day 1) and Week 8 | MITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 | Baseline (Day 1) and Week 8 | MITT population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | Placebo | -6.7 | Standard Error 2.68 | units on a scale | |
| Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | ADS-5102 (260 mg) | -12.3 | Standard Error 2.88 | units on a scale | |
| Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | ADS-5102 (340 mg) | -17.9 | Standard Error 2.82 | units on a scale | |
| Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 | ADS-5102 (420 mg) | -16.7 | Standard Error 2.88 | units on a scale | |
| Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | Placebo | -0.25 | Standard Error 0.267 | units on a scale | |
| Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | ADS-5102 (260 mg) | -0.06 | Standard Error 0.289 | units on a scale | |
| Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | ADS-5102 (340 mg) | -0.55 | Standard Error 0.280 | units on a scale | |
| Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 | ADS-5102 (420 mg) | 0.00 | Standard Error 0.287 | units on a scale | |
| Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | Placebo | -1.9 | Standard Error 1.19 | units on a scale | |
| Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 | ADS-5102 (260 mg) | -4.4 | Standard Error 1.26 | units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | STARTED | ADS-5102 (260 mg) | 20 | |
| Overall Study | STARTED | ADS-5102 (340 mg) | 21 | |
| Overall Study | STARTED | ADS-5102 (420 mg) | 20 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | COMPLETED | ADS-5102 (260 mg) | 17 | |
| Overall Study | COMPLETED | ADS-5102 (340 mg) | 18 | |
| Overall Study | COMPLETED | ADS-5102 (420 mg) | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | ADS-5102 (260 mg) | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events348
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 | Leukocytosis | Blood and lymphatic system disorders | Placebo | 0 | 22 | |
| other | Leukocytosis | Blood and lymphatic system disorders | ADS-5102 (260 mg) | 0 | 20 | |
| other | Leukocytosis | Blood and lymphatic system disorders | ADS-5102 (340 mg) | 0 | 21 | |
| other | Leukocytosis | Blood and lymphatic system disorders | ADS-5102 (420 mg) | 1 | 20 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 0 | 22 | |
| other | Angina pectoris | Cardiac disorders | ADS-5102 (260 mg) | 1 | 20 | |
| other | Angina pectoris | Cardiac disorders | ADS-5102 (340 mg) | 0 | 21 | |
| other | Angina pectoris | Cardiac disorders | ADS-5102 (420 mg) | 0 | 20 | |
| other | Vision blurred | Eye disorders | Placebo | 1 | 22 | |
| other | Vision blurred | Eye disorders | ADS-5102 (260 mg) | 1 | 20 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, all-cause mortality | ADS-5102 (260 mg) | 0 | 20 |
| Total, all-cause mortality | ADS-5102 (340 mg) | 0 | 21 |
| Total, all-cause mortality | ADS-5102 (420 mg) | 0 | 20 |
| Total, other adverse events | Placebo | 18 | 22 |
| Total, other adverse events | ADS-5102 (260 mg) | 16 | 20 |
| Total, other adverse events | ADS-5102 (340 mg) | 20 | 21 |
| Total, other adverse events | ADS-5102 (420 mg) | 18 | 20 |
| Total, serious adverse events | Placebo | 0 | 22 |
| Total, serious adverse events | ADS-5102 (260 mg) | 1 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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/NCT01397422
GET https://conductscience.org/api/trials/v1/NCT01397422/results?page=2