Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
NCT ID: NCT01397422
Last Updated: 2017-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
83 participants
INTERVENTIONAL
2011-07-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment C
A mid-dose ADS-5102 (amantadine extended release)
ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Treatment D
High dose ADS-5102 (amantadine extended release)
ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Treatment A
ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Treatment B
Low dose ADS-5102 (amantadine extended release)
ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Interventions
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ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
85 Years
ALL
No
Sponsors
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Adamas Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials Director
Role: STUDY_DIRECTOR
Adamas Pharmaceuticals, Inc.
Locations
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Sun City, Arizona, United States
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
Fairfield, Connecticut, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Winfield, Illinois, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
West Bloomfield, Michigan, United States
Toms River, New Jersey, United States
New York, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Kirkland, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ADS-PAR-AM201
Identifier Type: -
Identifier Source: org_study_id