Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)

Completed · Phase 2/Phase 3

Conditions studied: Dyskinesia, Levodopa Induced Dyskinesia, Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01397422

Run by

Adamas Pharmaceuticals, Inc.

People needed

83

Starts

2011-07-01

Expected to finish

2013-10-01

Last updated by the study team

2017-12-13

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Sun City, Arizona, United States
• Study site — Fountain Valley, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oxnard, California, United States
• Study site — Pasadena, California, United States
• Study site — Reseda, California, United States
• Study site — Sunnyvale, California, United States
• Study site — Ventura, California, United States
• Study site — Fairfield, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Winfield, Illinois, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — West Bloomfield, Michigan, United States
• Study site — Toms River, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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