TEMPO-1 Trial

Summary

The purpose of this study is to evaluate the effectiveness and safety of an investigational drug called CVL-751 (also known as tavapadon) as a possible treatment for Parkinson's disease. Tavapadon works by targeting the dopamine system in the brain. Participants will be randomly assigned to receive either the study drug or placebo (inactive substance); they will have a 67% (2 in 3) chance of receiving CVL-751 and a 33% (1 in 3) chance of receiving placebo. The study is divided into 3 time periods: a 4-week screening/baseline period, a 27-week treatment period, and a 4-week post-treatment follow-up period. During each study period, participants will have one or more visits with their study doctor.


Inclusion Criteria

  • Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF)
  • Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment
  • Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
  • Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria
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Study Location(s)

Beverly

More about this Clinical Trial

Full 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

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

III

IRB Number

STUDY00000561

ClinicalTrials.gov ID

NCT04201093

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

III

IRB Number

CVL-751-PD-001-TEMPO-1

ClinicalTrials.gov ID

NCT04201093

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?