Condition: Parkinson’s disease
Key Inclusion Criteria:
- Diagnosis of Parkinson’s disease 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 1, 1.5, or 2
- Disease duration (from time of diagnosis) of less than 3 years and disease progression in the 3 years before signing consent form
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 or 2 or more other antiparkinsonian drugs at therapeutic dosages
- Acute or chronic, clinically significant medical or psychiatric condition, cognitive impairment, or laboratory abnormality that would make the patient inappropriate for entry into this study
A Phase III, Double-Blind, Randomized, Placebo-Controlled Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson’s Disease (TEMPO-1 TRIAL) (IRB no. 00000561)
The purpose of this study is to evaluate the effectiveness and safety of an investigational drug called CVL-751 (also known as tavapadon) as a possible treatment for Parkinson’s disease. Tavapadon works by targeting the dopamine system in the brain. Participants will be randomly assigned to receive either the study drug or placebo (inactive substance); they will have a 67% (2 in 3) chance of receiving CVL-751 and a 33% (1 in 3) chance of receiving placebo.
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 follow-up period. During each study period, participants will have one or more visits with their study doctor.