Tavapadon for Parkinson's Disease

(TEMPO-4 Trial)

Not currently recruiting at 152 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term safety and effectiveness of a drug called tavapadon for people with Parkinson's Disease. Tavapadon, taken as a daily tablet, aims to manage symptoms over time. The trial seeks participants who have completed certain previous studies and can begin this trial promptly after their last visit. Participants must agree to use approved birth control methods or abstain from sex to ensure safety during the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment for Parkinson's Disease.

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).

Is there any evidence suggesting that tavapadon is likely to be safe for humans?

Studies have shown that tavapadon is generally safe. Most side effects reported in past trials were mild to moderate. Research indicates that people tolerate tavapadon well, with no serious side effects directly linked to its use. Long-term studies have also supported its safety, showing continued positive results for patients with Parkinson's Disease. While researchers are still collecting final data, current evidence suggests that tavapadon is a safe option for treating Parkinson's symptoms. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Tavapadon is unique because it targets Parkinson's disease with a novel approach, acting as a selective dopamine D1/D5 receptor partial agonist. This sets it apart from standard treatments like levodopa and dopamine agonists, which primarily focus on replacing or mimicking dopamine. By specifically modulating the D1/D5 receptors, Tavapadon aims to provide symptomatic relief while potentially reducing the side effects often associated with traditional therapies. Researchers are excited about Tavapadon's potential to improve movement symptoms with a more targeted action, offering hope for better managing Parkinson's disease.

What evidence suggests that tavapadon might be an effective treatment for Parkinson's Disease?

Studies have shown that tavapadon effectively treats Parkinson's disease. In clinical trials, patients taking tavapadon experienced 1.1 more hours of "ON time" each day—periods when symptoms are well-controlled—compared to those on a placebo. Importantly, this improvement did not result in troublesome movements. Research also indicates that tavapadon enhances motor skills and daily activities for people with Parkinson's. Additionally, it is generally safe and well-tolerated by patients. Overall, tavapadon shows promise for effectively managing Parkinson's symptoms. ^{1 2 4 6 7}

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12468602/

Emerging Clinical Role of Tavapadon, a Novel Dopamine ...

Multiple studies have demonstrated Tavapadon to be safe and effective in treating Parkinson's disease (PD) [18,19]. The half-life of Tavapadon ...

2.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000208468

Efficacy and Safety of Tavapadon, an Orally Administered ...

Treatment with tavapadon (5–15 mg once daily) significantly increased total daily ON time without troublesome dyskinesia by 1.1 hours relative to placebo.

3.

neurologylive.com

neurologylive.com/view/parkinson-agent-tavapadon-continued-efficacy-safety-phase-3-tempo-4-trial

Parkinson Agent Tavapadon Shows Continued Efficacy ...

Tavapadon demonstrated a favorable long-term safety profile and motor function improvements in Parkinson's disease patients in the TEMPO-4 study ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41002726/

Emerging Clinical Role of Tavapadon, a Novel Dopamine ...

In placebo-controlled trials, Tavapadon produced clear, clinically meaningful gains in motor function and day-to-day activities, as captured by ...

5.

news.abbvie.com

news.abbvie.com/2024-12-09-AbbVie-Announces-Positive-Topline-Results-for-the-Phase-3-TEMPO-2-Trial-Evaluating-Tavapadon-as-a-Monotherapy-for-Parkinsons-Disease

AbbVie Announces Positive Topline Results for the Phase ...

Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-2 flexible-dose monotherapy trial, demonstrating a statistically significant ...

6.

news.abbvie.com

news.abbvie.com/2025-09-26-AbbVie-Submits-New-Drug-Application-to-U-S-FDA-for-Tavapadon-for-the-Treatment-of-Parkinsons-Disease

AbbVie Submits New Drug Application to U.S. FDA for ...

The submission is based on results from the TEMPO clinical development program that evaluated the efficacy, safety and tolerability of tavapadon ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04201093

Fixed-Dose Trial in Early Parkinson's Disease (PD)

The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with ...