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

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adamas Pharmaceuticals, Inc.
• Treatments: Amantadine; Levodopa

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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