Tavapadon for Parkinson's Disease

(TEMPO-3 Trial)

No longer recruiting at 167 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called tavapadon for people with Parkinson's Disease who experience motor fluctuations. The goal is to determine if tavapadon can increase the daily hours when symptoms are controlled without causing troublesome movements. Participants will receive either tavapadon or a placebo (a pill with no active medication) for 27 weeks. Ideal candidates for this trial have used a stable dose of L-Dopa for at least 4 weeks and experience at least two and a half hours of "off" time, where symptoms return, each day. 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.

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.

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, with most side effects being mild to moderate. For instance, one study reported no deaths, and only 1.3% of patients experienced unusual urges, such as gambling or overeating. Another study confirmed that tavapadon has mild side effects and is well-tolerated by patients in the early stages of the disease.

Various studies suggest that the long-term safety of tavapadon looks promising. This indicates that tavapadon could be a safe treatment option for people with Parkinson's considering participation in a clinical trial. ^{1 2 3 4 5}

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

Researchers are excited about tavapadon for Parkinson's disease because it offers a new approach by specifically targeting dopamine D1/D5 receptors, which are thought to play a key role in motor control. Unlike the standard treatments that often focus on replacing dopamine or inhibiting its breakdown, tavapadon works by selectively stimulating these receptors, potentially leading to improved motor function and fewer side effects. This targeted mechanism might result in better symptom management and enhanced quality of life for patients with Parkinson's disease.

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

Research has shown that tavapadon, which participants in this trial may receive, effectively treats Parkinson's disease. Studies have found that it improves movement and increases daily "on" time—periods when symptoms are well managed—without causing troublesome uncontrolled movements. Specifically, one study found that tavapadon increased "on" time by 1.1 hours more than a placebo. The treatment is also considered safe, as most patients can use it without serious side effects. These findings suggest tavapadon could help manage movement issues in people taking L-Dopa for Parkinson's. ^{1 2 3 6 7}

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

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. news.abbvie.com news.abbvie.com/2024-09-26-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-TEMPO-1-Trial-Evaluating-Tavapadon-as-a-Monotherapy-for-Parkinsons-Disease

AbbVie Announces Positive Topline Results from Phase 3 ... Tavapadon met the primary endpoint in the pivotal Phase 3, TEMPO-1 fixed-dose monotherapy trial, demonstrating a statistically significant ...

7. medcentral.com medcentral.com/neurology/parkinsons/early-parkinsons-disease-drug-tavapadon-effective-safe-in-tempo-trials

Early Parkinson's Disease Drug Tavapadon Effective, Safe ... The majority of treatment-emergent adverse events were mild or moderate, with no deaths reported. ICD occurred in 1.3% of patients assigned ...