Tavapadon for Parkinson's Disease

(TEMPO-4 Trial)

Recruiting at 139 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Levodopa/carbidopa

Must not be taking: Dopaminergic agents

Disqualifiers: Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 58 weeks

992 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 to see if it is safe and effective for people with Parkinson's Disease. The medication aims to help manage symptoms like tremors and stiffness by targeting specific parts of the brain.

Will I have to stop taking my current medications?

The trial requires participants to refrain from any Parkinson's Disease medications not allowed by the protocol, but those from Trial CVL-751-PD-003 must continue using levodopa/carbidopa (or levodopa/benserazide).

Who Is on the Research Team?

ABBVIE Inc.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who were part of certain previous trials and can start this one within 72 hours after the last visit. They must use effective birth control or abstain, be able to follow the study rules, avoid unapproved PD medications, and have been compliant in past trials.

Inclusion Criteria

Participants who demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial

I am joining this trial within 3 days of finishing my last trial.

Participants willing and able to refrain from any PD medications not permitted by the protocol throughout participation in the trial

Exclusion Criteria

Rollover participants who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial

The doctor thinks you may be at risk of hurting yourself.

You were previously in this trial and then decided to leave.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tavapadon at a dose of 5 mg to 15 mg once daily during a 58-week treatment period

58 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Tavapadon

Trial Overview The study tests long-term safety and effectiveness of varying doses of tavapadon in treating Parkinson's Disease. It's an open-label trial, meaning both researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: Tavapadon Experimental Treatment 1 Intervention

Participants will receive a Tavapadon tablet at a dose of 5 milligrams (mg) to 15 mg once daily (QD) orally during 58-week treatment period.

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+