Clinical Trial TitleA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for PD in Levodopa-Treated Adults With Motor Fluctuations
National Clinical Trial Number:NCT045424499
Clinical Trial Protocol Description:
The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's disease (PD) who are experiencing motor fluctuations.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a modified Hoehn and Yahr stage 2, 2.5, or 3 in the "on" state.
- Have a good response to levodopa (L-Dopa) in the judgment of the investigator.
- Return a completed self-reported home diary for motor function status (Hauser diary) during the screening period (after diary training and concordance testing has occurred), with recordings for 2 consecutive days (ie, 2 consecutive 24-hour periods) showing at least 2 and half hours of "off" time on each of the 2 days.
- Are on a stable dose of L-Dopa for at least 4 weeks prior to screening and are taking a minimum total daily dose of 400 milligram (mg) divided in at least 4 doses per day of standard carbidopa/levodopa or divided in at least 3 doses per day of extended-release carbidopa/levodopa capsules.
You will be excluded from the study if any of the following criteria apply to 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 poststroke parkinsonism).
- Have a history of nonresponse or insufficient response to L-Dopa 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.