TEMPO-3 Trial

Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called CVL-751 (also known as tavapadon) as a possible adjunctive (supportive) treatment for Parkinson's disease. Tavapadon works by targeting the dopamine system in the brain and is being investigated to determine whether it can further improve Parkinson's disease symptoms when combined with a drug called levodopa. Specifically, researchers aim to learn how well tavapadon works and how safe it is when combined with patients' current levodopa (L-Dopa) treatment. Participants will be randomly assigned to receive either the study drug or placebo (inactive substance). 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 safety 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 this protocol.
  • Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry.
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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, FLEXIBLE-DOSE, 27-WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAVAPADON AS ADJUNCTIVE THERAPY FOR PARKINSON?S DISEASE IN LEVODOPA-TREATED ADULTS WITH MOTOR FLUCTUATIONS

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Co-Investigators

Echo Tan, Elliot Hogg

Age Group

Adult

Phase

III

IRB Number

STUDY00001145

ClinicalTrials.gov ID

NCT04542499

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-003

ClinicalTrials.gov ID

NCT04542499

Key Eligibility
ClinicalTrials.gov

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