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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)
Must not have
Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy, or seizures
Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 weeks
Awards & highlights
Pivotal 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.
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.
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.

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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My condition was diagnosed less than 3 years ago and has gotten worse since then.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of brain tumor, severe head trauma, epilepsy, or seizures.
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I have been diagnosed with or show signs of essential tremor or atypical parkinsonism.
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I understand the consent form and can participate in the trial.
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I experience significant dizziness when standing up.
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I haven't had serious heart issues like a heart attack or heart failure in the last year.
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I am currently taking medication that strongly affects liver enzymes.
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L-Dopa treatments haven't worked well for me.
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My kidneys do not work well.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score
Secondary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
36 Previous Clinical Trials
5,020 Total Patients Enrolled
Matthew Leoni, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
1,969 Total Patients Enrolled
Cari Combs, MDStudy DirectorCerevel Therapeutics, LLC
3 Previous Clinical Trials
1,803 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
~87 spots leftby Dec 2025
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