A Study to Evaluate an Investigational Drug (tavapadon) as a Possible Treatment in Early Parkinson’s Disease
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)
The main purpose of this study is to learn how well tavapadon (the study drug) works as a possible treatment for Parkinson’s disease and how safe the study drug is. The target dose range of tavapadon being studied is 5 to 15 mg once daily.
If you choose to participate in this study, you may receive the study drug, or you may receive placebo. A placebo is an inactive material, such as a sugar pill, that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
You will be in this study for approximately 35 weeks, which includes a screening visit and safety follow up, and you will need to come to the study center at least 11 times over this period.
You may be eligible if you:
• Are Between the ages of 40 to 80 years
• Are willing to practice effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial if you are a sexually active man or woman of childbearing potential
• Were diagnosed more than 3 years ago
• Willing and able to not use any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.
You will be excluded if you:
• Have a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post-stroke parkinsonism).
• Have had previous surgical intervention (eg, deep brain stimulation) for PD or for whom such a procedure is planned or anticipated during the trial period.
• Have hypertension.
• Have previously participated in any tavapadon trial, including this trial, and received IMP.
• Have received treatment with any other investigational drug within 60 days before signing the ICF.