Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
EASED
1 other identifier
interventional
83
1 country
33
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2011
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
November 6, 2017
CompletedDecember 13, 2017
November 1, 2017
1.8 years
July 18, 2011
October 7, 2017
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to 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.
Baseline (Day 1) and Week 8
Secondary Outcomes (5)
Change in the Fatigue Severity Score (FSS) From Baseline to Week 8
Baseline (Day 1) and Week 8
Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8
Baseline (Day 1) and Week 8
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
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
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
Baseline (Day 1) and Week 8
Study Arms (4)
Treatment A
PLACEBO COMPARATORTreatment B
ACTIVE COMPARATORLow dose ADS-5102 (amantadine extended release)
Treatment C
ACTIVE COMPARATORA mid-dose ADS-5102 (amantadine extended release)
Treatment D
ACTIVE COMPARATORHigh dose ADS-5102 (amantadine extended release)
Interventions
Oral capsules to be administered once daily at bedtime, for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Sun City, Arizona, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Oxnard, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
Reseda, California, United States
Unknown Facility
Sunnyvale, California, United States
Unknown Facility
Ventura, California, United States
Unknown Facility
Fairfield, Connecticut, United States
Unknown Facility
Boca Raton, Florida, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Port Charlotte, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Winfield, Illinois, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Kansas City, Kansas, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
West Bloomfield, Michigan, United States
Unknown Facility
Toms River, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Kirkland, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head, Regulatory Affairs
- Organization
- Adamas Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trials Director
Adamas Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 19, 2011
Study Start
July 1, 2011
Primary Completion
May 1, 2013
Study Completion
October 1, 2013
Last Updated
December 13, 2017
Results First Posted
November 6, 2017
Record last verified: 2017-11