Condition: Parkinson’s disease
Key Inclusion Criteria:
- Diagnosis of Parkinson’s disease that is consistent with the UK Parkinson’s Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry
- Participants who complete the 27-week double-blind Treatment Period of the TEMPO-1 or TEMPO-3 studies and enter this trial within 72 hours after completing the last trial visit in the double-blind trial
- Modified Hoehn and Yahr stage 1, 1.5, 2, 2.5, or 3
Key Exclusion Criteria:
- History or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome
- History of nonresponse or insufficient response to L-Dopa at therapeutic dosages based on medical records or subject/caregiver feedback
58-Week Open-Label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 TRIAL) (IRB no. 00001372)
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.