Tavapadon for Parkinson's Disease

(TEMPO-2 Trial)

Recruiting at 56 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: MAO-B inhibitors

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: Unknown

Duration: 27 weeks

304 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to refrain from taking certain Parkinson's Disease medications that are not allowed by the protocol, including dopaminergic agents. However, if you are using MAO-B inhibitors, you can continue as long as the dosage remains stable throughout the trial.

What is the purpose of this trial?

This trial is testing a medication called tavapadon to see if it can help people with Parkinson's Disease. The study will check how well the medication works, how safe it is, and how the body processes it. Tavapadon aims to balance brain chemicals that control movement, potentially reducing Parkinson's symptoms.

Research Team

ABBVIE Inc.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

I agree to use effective birth control or remain abstinent during and 4 weeks after the trial.

My condition has worsened in the last 3 years and it started less than 3 years ago.

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

Exclusion Criteria

I have a condition that might affect how my body absorbs medication.

I have moderate to severe kidney problems.

You are at risk of hurting yourself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

27 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Tavapadon

Trial Overview 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.

Participant Groups

Group I: Tavapadon Experimental Treatment 1 Intervention

Participants will receive tavapadon tablet titrated up to 15 milligram (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?

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

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+