Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study) (EASED)
![]() |
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: NCT01397422 |
Recruitment Status :
Completed
First Posted : July 19, 2011
Results First Posted : November 6, 2017
Last Update Posted : December 13, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyskinesia Levodopa Induced Dyskinesia Parkinson's Disease | Drug: ADS-5102 (extended release amantadine HCl) | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study) |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Treatment A |
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks |
Active Comparator: Treatment B
Low dose ADS-5102 (amantadine extended release)
|
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks |
Active Comparator: Treatment C
A mid-dose ADS-5102 (amantadine extended release)
|
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks |
Active Comparator: Treatment D
High dose ADS-5102 (amantadine extended release)
|
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks |
- Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 [ Time Frame: 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.
- Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 [ Time Frame: 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.
- Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 [ Time Frame: 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.
- 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 [ Time Frame: 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.
- Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 [ Time Frame: 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.
- Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 [ Time Frame: 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed a current IRB/IEC-approved informed consent form
- Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
- On a stable regimen of antiparkinson's medications , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
- Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)
- Able to understand and complete a standardized PD home diary, following training
Exclusion Criteria:
- History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
- History of seizures or stroke/TIA within 2 years of screening
- History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
- Estimated GFR < 50 mL/min/1.73m2
- Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening
- If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose
- If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment
- Treatment with an investigational drug or device within 30 days prior to screening
- Treatment with an investigational biologic within 6 months prior to screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397422
United States, Arizona | |
Sun City, Arizona, United States | |
United States, California | |
Fountain Valley, California, United States | |
Long Beach, California, United States | |
Los Angeles, California, United States | |
Oxnard, California, United States | |
Pasadena, California, United States | |
Reseda, California, United States | |
Sunnyvale, California, United States | |
Ventura, California, United States | |
United States, Connecticut | |
Fairfield, Connecticut, United States | |
United States, Florida | |
Boca Raton, Florida, United States | |
Bradenton, Florida, United States | |
Port Charlotte, Florida, United States | |
Tampa, Florida, United States | |
United States, Georgia | |
Atlanta, Georgia, United States | |
Augusta, Georgia, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
Winfield, Illinois, United States | |
United States, Iowa | |
Des Moines, Iowa, United States | |
United States, Kansas | |
Kansas City, Kansas, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, Michigan | |
West Bloomfield, Michigan, United States | |
United States, New Jersey | |
Toms River, New Jersey, United States | |
United States, New York | |
New York, New York, United States | |
United States, North Carolina | |
Durham, North Carolina, United States | |
Raleigh, North Carolina, United States | |
United States, Ohio | |
Toledo, Ohio, United States | |
United States, Oklahoma | |
Tulsa, Oklahoma, United States | |
United States, Texas | |
Houston, Texas, United States | |
San Antonio, Texas, United States | |
United States, Virginia | |
Richmond, Virginia, United States | |
United States, Washington | |
Kirkland, Washington, United States | |
United States, Wisconsin | |
Milwaukee, Wisconsin, United States |
Study Director: | Clinical Trials Director | Adamas Pharmaceuticals, Inc. |
Responsible Party: | Adamas Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01397422 |
Other Study ID Numbers: |
ADS-PAR-AM201 |
First Posted: | July 19, 2011 Key Record Dates |
Results First Posted: | November 6, 2017 |
Last Update Posted: | December 13, 2017 |
Last Verified: | November 2017 |
Levodopa-induced dyskinesia Parkinsonism |
Parkinson Disease Dyskinesias Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Neurologic Manifestations Amantadine |
Antiparkinson Agents Anti-Dyskinesia Agents Antiviral Agents Anti-Infective Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |