Tavapadon for Parkinson's Disease
(TEMPO-3 Trial)

Recruiting in Palo Alto (17 mi)

+152 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Cerevel Therapeutics, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called tavapadon. It aims to help people with Parkinson's Disease who are already taking L-Dopa and experiencing varying symptoms throughout the day. The goal is to increase the number of hours they have good control over their movements without troublesome involuntary movements.

Eligibility Criteria

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.

Inclusion Criteria

My Parkinson's disease is at a moderate stage.

I can sign and follow the study's consent form and rules.

I have completed a diary showing I have at least 2.5 hours of 'off' time for 2 days.

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Exclusion Criteria

I have a history or symptoms of essential tremor or other non-standard Parkinson-like conditions.

I have or had a brain tumor, severe head injury, epilepsy, or seizures.

You have had suicidal thoughts or behaviors recently or are at high risk of committing suicide according to the investigator's opinion.

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Treatment Details

Interventions

Placebo (Adjunctive Therapy)
Tavapadon (Dopamine Agonist)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TavapadonExperimental Treatment1 Intervention

Participants will receive a tavapadon tablet titrated 5 to 15milligrams (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.