Tavapadon for Parkinson's Disease

(TEMPO-3 Trial)

Recruiting at 152 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cerevel Therapeutics, LLC

Must be taking: L-Dopa

Must not be taking: CYP3A4 inducers/inhibitors

Disqualifiers: Psychosis, Substance abuse, Cognitive impairment, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 27 weeks

507 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications if you are on a stable dose of L-Dopa or certain other medications like COMT inhibitors, MAO-B inhibitors, amantadine, istradefylline, or anticholinergic drugs, as long as these were started more than 90 days before the trial and the dosage remains stable during the trial.

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tavapadon or placebo titrated 5 to 15 mg once daily for 27 weeks

27 weeks

Visits at Weeks 2, 5, 8, 11, 14, 18, 22, and 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tavapadon

Trial Overview 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.

How Is the Trial Designed?

Group I: Tavapadon Experimental Treatment 1 Intervention

Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

Who Is Running the Clinical Trial?

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois