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Dopamine Agonist

Tavapadon for Parkinson's Disease (TEMPO-4 Trial)

Phase 3
Waitlist Available
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), weeks 32 and 58
Awards & highlights

TEMPO-4 Trial Summary

This trial will look at the safety and effectiveness of a drug called tavapadon for people with Parkinson's Disease.

Who is the study for?
This trial is for people with Parkinson's Disease who were part of certain previous trials and can start this one within 72 hours after the last visit. They must use effective birth control or abstain, be able to follow the study rules, avoid unapproved PD medications, and have been compliant in past trials.Check my eligibility
What is being tested?
The study tests long-term safety and effectiveness of varying doses of tavapadon in treating Parkinson's Disease. It's an open-label trial, meaning both researchers and participants know what treatment is being given.See study design
What are the potential side effects?
While not specified here, common side effects for Parkinson’s treatments like tavapadon may include nausea, dizziness, insomnia, dry mouth or constipation. Each person might experience these differently.

TEMPO-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), weeks 32 and 58
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), weeks 32 and 58 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index
Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS)
Change From Baseline in the Hauser diary
+7 more

TEMPO-4 Trial Design

1Treatment groups
Experimental Treatment
Group I: TavapadonExperimental Treatment1 Intervention
Participants will receive a Tavapadon tablet at a dose of 5 milligrams (mg) to 15 mg once daily (QD) orally during 58-week treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tavapadon
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
34 Previous Clinical Trials
4,495 Total Patients Enrolled
Matthew Leoni, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
1,484 Total Patients Enrolled
Cari Combs, MDStudy DirectorCerevel Therapeutics, LLC
3 Previous Clinical Trials
1,318 Total Patients Enrolled

Media Library

Tavapadon (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04760769 — Phase 3
Parkinson's Disease Research Study Groups: Tavapadon
Parkinson's Disease Clinical Trial 2023: Tavapadon Highlights & Side Effects. Trial Name: NCT04760769 — Phase 3
Tavapadon (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04760769 — Phase 3
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04760769 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this be the first time that this type of clinical trial has been performed?

"Research for Tavapadon began in 2019 with a clinical trial sponsored by Cerevel Therapeutics, LLC. A second study was conducted that same year which resulted in Tavapadon's approval as a Phase 3 drug. Currently, there are 4 active studies being conducted in 85 cities and 14 countries."

Answered by AI

How many trial subjects are involved in this research?

"Unfortunately, this particular trial is no longer recruiting patients. It was originally posted on February 24th, 2021 and had its last update September 7th, 2022. If you are still seeking trials to participate in, there are 515 other studies for Parkinson's disease and 4 for Tavapadon currently looking for participants."

Answered by AI

To what extent does this study's population reflect a cross-section of society?

"This clinical trial is open to 531 people with parkinson disease, aged 40-80. In order to be eligible, patients must meet the following criteria: They must have completed a previous 27 week double-blind treatment period from one of three trials, and enter this trial within 72 hours of their last visit from that study. Additionally, participants must agree to use birth control throughout the duration of the trial if they are sexually active, and refrain from taking any medication not permitted by the protocol. Lastly, investigators must judge the participant as being compliant with IMP requirements and willing to follow all restrictions laid out in the ICF and protocol."

Answered by AI

Are adults above the age of 25 able to participate in this clinical trial?

"Eligibility requirements for this study show that patients must be between 40-80 years old. In contrast, there are 29 trials specifically for children and 516 studies searching for elderly participants."

Answered by AI

Are there other cases in which Tavapadon has been tested in a controlled setting?

"Tavapadon was first studied in 2019 at Springub. Since then, there have been a total of six completed studies. There are four active clinical trials underway as of now; many of these are being conducted in Phoenix, Arizona."

Answered by AI

Are there any adverse effects associated with Tavapadon use?

"Tavapadon's safety is estimated to be a 3 by our team at Power. This is due to the fact that Tavapadon is currently in Phase 3 clinical trials, meaning there have been multiple rounds of data supporting its efficacy and safety."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What site did they apply to?
Pasadena, California
Rock Hill, South Carolina
Durham, North Carolina
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2

What questions have other patients asked about this trial?

How many total trips to Durham will be required and will I be reimbursed for mileage?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I support research whenever possible. I've only tried L-DOPA and I would like to try new medications and stem cell transplant.
PatientReceived 1 prior treatment
~414 spots leftby Jan 2026