Tavapadon for Parkinson's Disease

(TEMPO-2 Trial)

No longer recruiting at 62 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, tavapadon, to evaluate its effectiveness and safety for people with Parkinson's Disease. Researchers aim to determine if tavapadon can help manage symptoms in individuals who have had Parkinson's for less than three years and are in the early stages of the disease. Participants will receive either tavapadon or a placebo (a pill with no active drug) for 27 weeks. This trial may suit those recently diagnosed with Parkinson's and experiencing changes that might require medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

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

Research has shown that tavapadon is generally well-tolerated by people with Parkinson's Disease. Most side effects are mild to moderate, meaning they are not too serious and can often be managed. For example, one study found that tavapadon caused only mild side effects in patients with early-stage Parkinson’s. Another study confirmed its safety for long-term use, while also helping patients improve their movement.

Overall, these findings suggest that tavapadon is safe enough for further testing in trials. However, side effects can still occur, and each person's experience may differ. ^{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 in a fresh way by acting as a selective dopamine D1/D5 receptor agonist. This is different from the usual treatments like levodopa, which generally increase dopamine levels broadly. Researchers are excited because this targeted approach may reduce the risk of common side effects, such as dyskinesia, and potentially offer improved motor symptom control. This could mean a better quality of life for people with Parkinson's disease.

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

Research shows that Tavapadon, which participants in this trial may receive, effectively treats Parkinson's disease. Studies have found that Tavapadon increases the "ON" time—when patients experience better movement control without unwanted movements—by 1.1 hours compared to a placebo. The TEMPO-4 study found it safe for long-term use and effective in improving movement abilities. These findings suggest that Tavapadon can effectively help manage Parkinson's disease symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE Inc.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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.

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 ...

3.

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.

4.

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 ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05610189

Study Details | NCT05610189 | Multiple-dose Trial to ...

The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with ...

6.

prd-journal.com

prd-journal.com/article/S1353-8020(25)00364-5/fulltext

Tavapadon, an Orally Administered, Once-Daily, Selective D1 ...

Conclusions: TEMPO-3 outcomes demonstrate the efficacy, tolerability, and acceptable safety profile of adjunctive tavapadon for treatment of PD in levodopa- ...