Overview

This trial is active, not recruiting.

Conditions dyskinesia, levodopa induced dyskinesia (lid), parkinson's disease (pd)
Treatment ads-5102
Phase phase 3
Sponsor Adamas Pharmaceuticals, Inc.
Start date July 2014
End date August 2017
Trial size 250 participants
Trial identifier NCT02202551, ADS-AMT-PD302

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
amantadine HCl extended release
ads-5102 amantadine HCl extended release

Primary Outcomes

Measure
Safety and tolerability of ADS-5102 assessed by adverse events, safety-related study drug discontinuation, vital signs, and safety laboratory tests
time frame: Up to 105 weeks

Secondary Outcomes

Measure
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
time frame: Up to 105 weeks

Eligibility Criteria

Male or female participants from 30 years up to 85 years old.

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

Additional Information

Official title Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Adamas Pharmaceuticals, Inc..