Status:
COMPLETED
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
Lead Sponsor:
Adamas Pharmaceuticals, Inc.
Conditions:
Dyskinesia
Levodopa-Induced Dyskinesia (LID)
Eligibility:
All Genders
30-85 years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational for...
Eligibility Criteria
Inclusion
- Signed a current IRB/REB/IEC-approved informed consent form;
- Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria;
- On a stable regimen of antiparkinson's medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation;
- Following diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (trained caregiver/study partner assistance allowed);
- Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis);
Exclusion
- History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation);
- History of seizures within 2 years prior to screening;
- History of stroke or TIA within 2 years prior to screening;
- History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer, in situ cervical cancer, or other definitively treated cancer that is considered cured;
- 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, using one of the following: barrier methods (diaphragm or partner using condoms plus use of spermicidal jelly or foam, preferably double-barrier methods); oral or implanted hormonal contraceptive; intrauterine device (IUD); or vasectomized male partner;
- Treatment with an investigational drug or device within 30 days prior to screening;
- Treatment with an investigational biologic within 6 months prior to screening;
- Current participation in another clinical trial;
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2016
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT02274766
Start Date
October 1 2014
End Date
March 10 2016
Last Update
January 10 2018
Active Locations (51)
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1
Fountain Valley, California, United States, 92708
2
Sunnyvale, California, United States, 94085
3
Boca Raton, Florida, United States, 33486
4
Jacksonville, Florida, United States, 32209