Tavapadon for Parkinson's Disease
(TEMPO-4 Trial)
Recruiting at 139 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AbbVie
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Trial Summary
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.
Research Team
AI
ABBVIE Inc.
Principal Investigator
AbbVie
Eligibility Criteria
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
See 2 more
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.
See 1 more
Treatment Details
Interventions
- Tavapadon
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TavapadonExperimental Treatment1 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.
Find a Clinic Near You
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+
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