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

Palo Alto (17 mi)

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've been on a stable dose of L-Dopa for Parkinson's, at least 400 mg daily, for over 4 weeks.

I am between 40 and 80 years old.

I have Parkinson's with slow movements and uneven symptoms on both sides.

My Parkinson's disease is at a moderate stage.

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

I've been on a stable dose of L-Dopa for Parkinson's, at least 400 mg daily, for over 4 weeks.

Exclusion Criteria

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

My condition did not improve with L-Dopa treatment.

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

I haven't had serious heart issues or uncontrolled heart rhythm problems in the last year.

I am not taking any strong medication that affects liver enzymes.

I have severe dizziness or fainting when standing up.

My kidneys are not working well or I am on dialysis.

Treatment Details

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.

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.