Status:
COMPLETED
Open-Label Safety Study of ADS-5102 in PD Patients With LID
Lead Sponsor:
Adamas Pharmaceuticals, Inc.
Conditions:
Dyskinesia
Levodopa Induced Dyskinesia (LID)
Eligibility:
All Genders
30-85 years
Phase:
PHASE3
Brief 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...
Detailed Description
Participation in this study was offered to subjects who were described by one of the following 3 groups: * Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and chos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT02202551
Start Date
July 1 2014
End Date
February 1 2018
Last Update
October 6 2020
Active Locations (87)
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1
Birmingham, Alabama, United States, 35233
2
Phoenix, Arizona, United States, 85013
3
Scottsdale, Arizona, United States, 85259
4
Sun City, Arizona, United States, 85351