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Dopamine Agonist

Tavapadon for Parkinson's Disease (TEMPO-2 Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexually active men or women of childbearing potential must agree to use acceptable 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 and complying with the requirements and restrictions listed in the informed consent form and in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 weeks
Awards & highlights

TEMPO-2 Trial Summary

This trial will evaluate a new drug for Parkinson's Disease to see if it is effective, safe, and well tolerated.

Who is the study for?
This trial is for men and women aged 40-80 with early Parkinson's Disease (PD) who need medication to manage their condition. They must not have used PD medications recently, agree to birth control if applicable, and be able to follow the study rules. People with dementia, significant heart issues, drug abuse history, or certain other health problems can't join.Check my eligibility
What is being tested?
The trial is testing tavapadon against a placebo in people with early PD. It aims to see how well tavapadon works and its effects on the body when doses are adjusted based on patients' needs compared to no active treatment.See study design
What are the potential side effects?
While specific side effects of tavapadon aren't listed here, common ones may include nausea, dizziness, sleepiness or insomnia which are typical for drugs affecting brain function like those used in PD.

TEMPO-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control or remain abstinent during and 4 weeks after the trial.
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I can sign the consent form and follow the study's requirements.
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You have been diagnosed with Parkinson's disease according to specific criteria from the UK Parkinson's Disease Society Brain Bank.
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My Parkinson's disease is in the early stages.
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My condition has worsened in the last 3 years and it started less than 3 years ago.
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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.
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I have either not been treated or only had short-term treatment with dopamine drugs.
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I can stop taking certain Parkinson's disease medications if needed for the trial.

TEMPO-2 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-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TavapadonExperimental Treatment1 Intervention
Participants will receive tavapadon tablet titrated up to 15 milligram (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
5,387 Total Patients Enrolled
Matthew Leoni, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
2,388 Total Patients Enrolled
Cari Combs, MDStudy DirectorCerevel Therapeutics, LLC
3 Previous Clinical Trials
2,222 Total Patients Enrolled

Media Library

Tavapadon (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04223193 — Phase 3
Parkinson's Disease Research Study Groups: Tavapadon, Placebo
Parkinson's Disease Clinical Trial 2023: Tavapadon Highlights & Side Effects. Trial Name: NCT04223193 — Phase 3
Tavapadon (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04223193 — Phase 3
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04223193 — Phase 3

Frequently Asked Questions

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

Would I be able to qualify to participate in this research study?

"This is a study for people with Parkinson's disease aged from 40 to 80. The main requirements are as follows: The participant must be male or female, and aged 40 to 80 years old when they sign the informed consent form. They must be able to understand and sign the informed consent form. They must have a modified Hoehn and Yahr stage of 1, 1.5, or 2. They must have had the disease for less than 3 years, and the disease must have progressed in the 3 years before signing the informed consent form. They must have an MDS-UPDRS Part II score of 2 or more and"

Answered by AI

Can adults of any age join this research project?

"This trial is for patients who are aged 40 to 80. There are currently 29 clinical trials underway for people younger than 18 and 509 for patients older than 65."

Answered by AI

How many different hospitals are coordinating this trial?

"To make the process as convenient as possible for participants, the clinical trial is being conducted at 17 sites. These locations include Syracuse, Fresno, Coral Springs and 14 other cities."

Answered by AI

Are there still spots open for people who want to participate in this experiment?

"That is correct, the online information does show that this study is recruiting patients. The trial was first announced on January 6th, 2020 and has since been updated on September 7th, 2020. They are looking for a total of 296 patients spread out over 17 different locations."

Answered by AI

How many people are going to participate in this trial?

"That is correct. The clinical trial is ongoing, as denoted by the fact that it was posted on 1/6/2020 and updated as recently as 9/7/2022 on clinicaltrials.gov. They are looking for 296 participants who are willing to go to one of the 17 locations."

Answered by AI

When might the FDA approve Tavapadon?

"Tavapadon ranks highly in terms of safety due to the amount of Phase 3 trial data supporting both its efficacy and safety."

Answered by AI

Has Tavapadon been used in other medical research studies?

"Tavapadon was first studied in 2019 at the Padova medical research centre. As of now, there have been 18,249 completed studies. There are 4 active studies at the moment, with a few of them taking place in Syracuse, New york."

Answered by AI

Does this research study break new ground?

"There are 4 ongoing clinical trials for the medication Tavapadon in 85 cities and 14 countries. The first trial was completed in 2019 by Cerevel Therapeutics, LLC. That particular study reached Phase 3 and had 522 participants. Since then, 18249 more trials have been run."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
New York
Washington
What site did they apply to?
Fresno, California
Port Charlotte, Florida
Albany, New York
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

i want to support research. My symtoms continue To get worse, so i am looking for options.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
~32 spots leftby Oct 2024