What is the Purpose of this Study?
This study focuses on individuals who are 40-80 years old and have been diagnosed with Parkinson's disease. The purpose of the study is to determine the safety and effectiveness of an investigational drug called CVL-751 (tavapadon) as a possible treatment for Parkinson's disease. Tavapadon works by targeting the dopamine system in the brain. At Cedars-Sinai, only participants who complete the trials of tavapadon CVL-751-PD-001 and CVL-751-PD-003 will be eligible. The study is divided into 3 time periods: a 58-week treatment period, a 10-day safety/withdrawal assessment period and a 20-day safety follow-up period. During each study period, participants will have one or more visits with their study doctor.
Eligibility
- * Participants who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 (NCT04201093) or Trial CVL-751 PD-003 (NCT04542499) or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 (NCT04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover participants from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
- * Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
58-Week Open-label Trial of Tavapadon in Parkinson s Disease