Clinical Trial TitleA 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).
Clinical Trial Protocol Description:
The purpose of this study is to learn how well CVL-751 (study drug) works and how safe it is in subjects that have been diagnosed with Parkinson’s disease.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female, 40 to 80 years of age.
- Have disease duration of <3 years (from time of diagnosis).
- Have disease stage 1, 1.5 or 2.
You will be excluded from the study if any of the following criteria apply to you:
- Have had previous surgical intervention for PD (eg, deep brain stimulation) or for whom such a procedure is planned or anticipated during the trial period.
- Have a history or clinical features consistent with essential tremor or atypical or secondary parkinsonian syndromes (PSP, MSA).
- Have a history of nonresponse or insufficient response to L-Dopa or 2 or more other antiparkinsonian drugs at therapeutic dosages.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.