Tavapadon for Parkinson's Disease
(TEMPO-3 Trial)
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tavapadon or placebo titrated 5 to 15 mg once daily for 27 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cerevel Therapeutics, LLC
Lead Sponsor
AbbVie
Lead Sponsor
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
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-trialParkinson 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 ...
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.
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 ...
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 ...
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-trialsEarly 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 ...
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