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)Purpose
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.
Could this study be right for you?
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.