Condition: Parkinson’s disease
Key Inclusion Criteria:
- Diagnosis of Parkinson’s disease (PD) consistent with the UK Parkinson’s Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry
- 40-80 years old
- Modified Hoehn and Yahr stage 2, 2.5, or 3 in the “on” state
Key Exclusion Criteria:
- History or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome
- History of non-response or insufficient response to L-Dopa at therapeutic dosages
- Previous surgical intervention for PD or for whom such a procedure is planned or anticipated during the trial period
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 TRIAL) (IRB no. 00001145)
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called CVL-751 (also known as tavapadon) as a possible adjunctive (supportive) treatment for Parkinson’s disease. Tavapadon works by targeting the dopamine system in the brain and is being investigated to determine whether it can further improve Parkinson’s disease symptoms when combined with a drug called levodopa. Specifically, researchers aim to learn how well tavapadon works and how safe it is when combined with patients’ current levodopa (L-Dopa) treatment. Participants will be randomly assigned to receive either the study drug or placebo (inactive substance).
The study is divided into 3 time periods: a 4 week screening/baseline period, a 27-week treatment period, and a 4-week post-treatment safety follow-up period. During each study period, participants will have one or more visits with their study doctor.