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Dopamine Agonist

Tavapadon for Parkinson's Disease (TEMPO-1 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
Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol throughout participation in the trial
Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 weeks
Awards & highlights

TEMPO-1 Trial Summary

This trial is testing a new drug for early Parkinson's disease to see if it is safe and effective.

Who is the study for?
This trial is for men and women aged 40-80 with early Parkinson's Disease (PD), diagnosed within the last 3 years, who haven't taken PD medications recently. They must be able to consent, follow the study rules, and use effective birth control if needed. People with certain medical conditions or drug histories that could affect the study are not eligible.Check my eligibility
What is being tested?
The trial is testing two fixed doses of a drug called tavapadon against a placebo in people with early-stage PD. It aims to see how well tavapadon works, its safety profile, and how it moves through the body compared to no active treatment.See study design
What are the potential side effects?
While specific side effects for tavapadon aren't listed here, clinical trials often monitor for common issues like nausea, dizziness, sleep disturbances or other unexpected reactions related to nervous system function especially considering this is a medication aimed at treating Parkinson's.

TEMPO-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stop taking certain Parkinson's drugs not allowed in the study.
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I am between 40 and 80 years old.
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My Parkinson's disease is in the early stages.
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I haven't used Parkinson's medication for more than 3 months or within 2 months before joining this study.
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I can sign and follow the study's consent form and rules.
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I have been diagnosed with Parkinson's disease according to UK standards.
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My condition was diagnosed less than 3 years ago and has gotten worse since then.
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I am using or willing to use birth control or remain abstinent during and 4 weeks after the trial.
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I have been diagnosed with Parkinson's disease according to UK standards.
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My Parkinson's symptoms affect my daily activities and movement significantly.
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I have early Parkinson's disease and need medication to manage it.

TEMPO-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 weeks 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 Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score
Secondary outcome measures
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Combined Score
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II Score
+8 more

TEMPO-1 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tavapadon 5 mgExperimental Treatment1 Intervention
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks.
Group II: Tavapadon 15 mgExperimental Treatment1 Intervention
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
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
5,161 Total Patients Enrolled
Matthew Leoni, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
2,162 Total Patients Enrolled
Cari Combs, MDStudy DirectorCerevel Therapeutics, LLC
3 Previous Clinical Trials
1,996 Total Patients Enrolled

Media Library

Parkinson's Disease Research Study Groups: Placebo, Tavapadon 5 mg, Tavapadon 15 mg
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04201093 — Phase 3

Frequently Asked Questions

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

What is the FDA's position on Tavapadon?

"The safety of Tavapadon is estimated to be a 3. This assessment comes from Power, and it's based on the fact that this is a Phase 3 trial. That means there's some evidence that the drug works, as well as multiple rounds of data supporting its safety."

Answered by AI

Does this research include elderly people as test subjects?

"28 clinical trials are available for patients under 18 years of age, 518 are available for those over 65, while this trial is recruiting adults aged 40-80."

Answered by AI

Has there been any prior research on this topic?

"Tavapadon is being studied in 4 active clinical trials across 85 urban areas and 14 nations. The first ever trial for Tavapadon was completed in 2019. That year, the study- which was funded by Cerevel Therapeutics, LLC- included 522 patients and finished its Phase 3 drug approval process. Since then, a total of 18294 studies have been wrapped up."

Answered by AI

How many different locations are conducting this trial?

"Patients are currently being recruited in Houston, Texas; Ottawa, Ontario; Little Rock, Arkansas; and 34 other locations."

Answered by AI

Are people with the required qualifications able to participate in this trial right now?

"The trial is listed as currently seeking patients on clinicaltrials.gov, with the first posting date being December 13th, 2019 and the most recent update on September 7th, 2022."

Answered by AI

Does Tavapadon have a long history of research?

"Tavapadon is currently being investigated in 4 clinical trials, with the majority of those research projects at Phase 3. Although most of the Tavapadon trials are based out of Philadelphia, Pennsylvania, there are a total 380 locations running these studies."

Answered by AI

If I take part in this research, what are the guidelines I need to follow?

"This study is looking for 522 participants who are between the ages of 40 and 80 and have been diagnosed with Parkinson's disease. In addition to meeting this age and diagnosis criteria, potential participants must also: - Be sexually active men or women of childbearing potential that agree to use effective birth control methods or abstain from sexual activity during the trial and for 4 weeks after the last dose of trial treatment- Have a disease duration (from time of diagnosis) of less than 3 years and evidence of disease progression in the 3 years before signing informed consent- Be able to give signed informed consent which includes compliance with requirements"

Answered by AI

How many people have been cleared to enroll in this clinical trial?

"A total of 522 patients are needed to enroll in this trial, with specific inclusion criteria. This study is being conducted at multiple sites including Houston, Texas and Ottawa, Ontario."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Ontario
Other
California
What site did they apply to?
Birmingham, Alabama
Durham, North Carolina
Other
Fountain Valley, California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

If accepted, how often/how many times will I need to travel to Durham?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

any trial is important. I am an early stage patient looking for ways to slow progression of Parkinson’s.
PatientReceived no prior treatments
I've only tried L-DOPA and I would like to try new medications and stem cell transplant.
PatientReceived 2+ prior treatments
I have tried Carbidopa_Levadopa as prescribed by my neurologist, but had to stop because getting sick each time.
PatientReceived 2+ prior treatments
~47 spots leftby Sep 2024