Open-Label Safety Study of ADS-5102 in PD Patients With LID

Completed · Phase 3

Conditions studied: Dyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's Disease (PD)

In brief

This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).

Key facts

Study ID

NCT02202551

Run by

Adamas Pharmaceuticals, Inc.

People needed

223

Starts

2014-07-01

Expected to finish

2018-02-01

Last updated by the study team

2020-10-06

Who can join

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

You may qualify if…

• Signed a current IRB/REB/IEC-approved informed consent form
• Completed all study visits in previous Adamas efficacy study or were ineligible for participation in previous Adamas studies due to having undergone prior deep brain stimulation.
• Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
• On a stable regimen of antiparkinson's medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily.
• History of peak dose dyskinesia that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator

You may not qualify if…

• Discontinued ADS-5102 in previous Adamas efficacy study due to intolerable or unacceptable AEs considered to be related to ADS-5102
• History of neurosurgical intervention related to Parkinson's disease, with the exception of deep brain stimulation
• History of seizures since completion of participation in previous Adamas studies or within 2 years
• History of stroke or TIA since completion of participation in previous Adamas studies or within 2 years
• History of cancer since completion of participation in previous Adamas studies or within 2 years, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
• 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
• 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 (other than ADS-5102) or device within 30 days prior to screening
• Treatment with an investigational biologic within 6 months prior to screening
• Current or planned participation in another interventional clinical trial

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Sun City, Arizona, United States
• Study site — Fountain Valley, California, United States
• Study site — Pasadena, California, United States
• Study site — Reseda, California, United States
• Study site — Sacramento, California, United States
• Study site — Sunnyvale, California, United States
• Study site — Torrance, California, United States
• Study site — Ventura, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Manchester, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Sunrise, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Weston, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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