Expired Study
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Fountain Valley, California 92708


Purpose:

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).


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


NCT ID:

NCT02202551


Primary Contact:

Study Director
Clinical Trials Director
Adamas Pharmaceuticals, Inc.


Backup Contact:

N/A


Location Contact:

Fountain Valley, California 92708
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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