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Dopamine Agonist

Tavapadon for Parkinson's Disease (TEMPO-3 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 with modified Hoehn and Yahr stage 2, 2.5, or 3 in the "on" state.
Participants who 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. The carbidopa/levodopa dose and frequency must be maintained for the duration of the trial.
Timeline
Screening 31 days
Treatment 27 weeks
Follow Up 1 months
Awards & highlights

TEMPO-3 Trial Summary

This trial will test a new drug to see if it can reduce "on" time without troublesome dyskinesia in people with Parkinson's Disease who are already taking L-Dopa.

Who is the study for?
Adults aged 40-80 with Parkinson's Disease who respond well to L-Dopa, are on a stable dose of it, and experience at least 2.5 hours of 'off' time daily. They must use birth control or abstain if they can have children. Exclusions include psychosis history within the last year, significant cognitive impairment, substance abuse in the past 6 months, certain medical conditions affecting drug absorption or causing severe health risks.Check my eligibility
What is being tested?
The trial is testing Tavapadon as an additional treatment for Parkinson's alongside standard L-Dopa therapy versus a placebo. The main goal is to see if Tavapadon increases the daily 'on' time without troublesome dyskinesia (involuntary movements) compared to not taking it.See study design
What are the potential side effects?
Tavapadon may cause side effects such as nausea, headache, dizziness, sleep disturbances or unusual dreams. It might also lead to involuntary movements (dyskinesia), which will be closely monitored during the trial.

TEMPO-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Parkinson's disease is at a moderate stage.
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I've been on a stable dose of L-Dopa for Parkinson's, at least 400 mg daily, for over 4 weeks.
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I am between 40 and 80 years old.
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I have Parkinson's with slow movements and uneven symptoms on both sides.
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My Parkinson's disease is at a moderate stage.
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I have completed a diary showing I have at least 2.5 hours of 'off' time for 2 days.
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I've been on a stable dose of L-Dopa for Parkinson's, at least 400 mg daily, for over 4 weeks.

TEMPO-3 Trial Timeline

Screening ~ 31 days
Treatment ~ 27 weeks
Follow Up ~1 months
This trial's timeline: 31 days for screening, 27 weeks for treatment, and 1 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Change From Baseline in Total Daily "Off" Time Without Troublesome Dyskinesia Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score
+1 more

TEMPO-3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TavapadonExperimental Treatment1 Intervention
Participants will receive a tavapadon tablet titrated 5 to 15 milligrams (mg) once daily (QD) orally for 27 weeks.
Group II: 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
5,195 Total Patients Enrolled
Cari Combs, MDStudy DirectorCerevel Therapeutics, LLC
3 Previous Clinical Trials
2,018 Total Patients Enrolled
Matthew Leoni, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
2,184 Total Patients Enrolled

Media Library

Tavapadon (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04542499 — Phase 3
Parkinson's Disease Research Study Groups: Tavapadon, Placebo
Parkinson's Disease Clinical Trial 2023: Tavapadon Highlights & Side Effects. Trial Name: NCT04542499 — Phase 3
Tavapadon (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542499 — Phase 3
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04542499 — Phase 3

Frequently Asked Questions

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

Has Tavapadon been studied before in a different capacity?

"Tavapadon is currently being trialled in 4 studies, with the majority of those in Phase 3. A total of 380 research centres are running these live trials, with the most based in Kraków and Muenster."

Answered by AI

Who does this study hope to enroll?

"This clinical trial testing a new intervention for parkinson disease is looking for 368 participants that are between the ages of 40 and 80."

Answered by AI

If a patient is outside of the age bracket, can they still qualify for the program?

"The minimum age requirement for this particular clinical trial is 40 while the oldest a patient can be and still participate is 80."

Answered by AI

What are some of the harmful effects of Tavapadon on patients?

"Like many Phase 3 drugs, Tavapadon has undergone multiple rounds of testing to support its safety, and thus received a score of 3."

Answered by AI

Are there any other clinical trials like this one that have been conducted in the past?

"Tavapadon's clinical trials began in 2019. The first study was conducted by Cerevel Therapeutics, LLC and involved 522 patients. Tavapadon received Phase 3 approval after the first study and there are currently 4 trials underway in 85 cities and 14 countries."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
Fountain Valley, California
Frenso, California
Pasadena, California
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Texas
California
Ontario
Other
How many prior treatments have patients received?
3+
1
0

Why did patients apply to this trial?

Ive had DBS Surgery. Improve my quality of life. iv taken traditional therapies and am always looking for anything that can improve my health.
PatientReceived 2+ prior treatments
I am looking for other medications (other than L-Dopa) or stem cell transplant that might help with Parkinson's.
PatientReceived 2+ prior treatments
After DATscan my doctor told me I have Parkinese and put me on Carbidopa Levidopa. I want to stop the progression of this disease.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Pasadena, California: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations
2020. "Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04542499.
~113 spots leftby Apr 2025
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