Sponsor: Cerevel Therapeutics, LLC

Official title: A Phase 3, 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)

Purpose: To evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

Study design: Randomized, Double-blind, Placebo-controlled

Study duration: 27 Weeks

Basic inclusion criteria
1. Male and female participants aged 40 to 80 years, inclusive, at the time of signing the ICF (Informed consent form).
2. Participants with disease duration (from time of diagnosis) of less than (<) 3 years and disease progression in the 3 years before signing the informed consent form (ICF)
3. Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management
4. Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial

Basic Exclusion Criteria
1. Participants with a history of nonresponse or insufficient response to L-Dopa or 2 or more other antiparkinsonian drugs at therapeutic dosages
2. Participants with a history or current diagnosis of a clinically significant impulse control disorder 
3. Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures
4. Participants with a history of psychosis or hallucinations within the previous 12 months based on medical records or participant/caregiver feedback
5. Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding)