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Flexible-Dose Trial in Early Parkinson's Disease (PD) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)

NCT04223193•AbbVie

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF).
•Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment.
•Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
•Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria.
•Participants with modified Hoehn and Yahr stage 1, 1.5, or 2.
•Participants with disease duration (from time of diagnosis) of less than (\<) 3 years and disease progression in the 3 years before signing the ICF.
•Participants with an MDS-UPDRS Part II score \>=2 and Part III score \>=10 at the Screening Visit and at the Baseline Visit.
•Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management.
•Participants who are treatment naive or have a history of prior incidental treatment with dopaminergic agents (including L-Dopa and dopamine receptor agonist medications) for \<3 months in total but not within 2 months of the Baseline Visit. Prior and concurrent use of MAO-B inhibitors is permitted if use was initiated \>90 days before the Baseline Visit and the dosage will remain stable for the duration of the trial (ie, no change in the MAO-B inhibitor dose is permitted during the trial).
•Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.

Exclusion Criteria

•Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post stroke parkinsonism).
•Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages.
•Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5).
•Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures.
•Participants with a history of psychosis or hallucinations within the previous 12 months.
•Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
•Participants with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days).
•Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial.
•Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding).
•Participants who have a positive result for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies at screening.
+12 more criteria

Locations (53)

Fresno, California

Fresno, California, United States

Boca Raton, Florida

Boca Raton, Florida, United States

Maitland, Florida

Maitland, Florida, United States

Ocala, Florida

Ocala, Florida, United States

Winter Park, Florida

Winter Park, Florida, United States

Boston Neuro Research Center

North Dartmouth, Massachusetts, United States

Albany, New York

Albany, New York, United States

Syracuse, New York

Syracuse, New York, United States

Cincinnati, Ohio

Cincinnati, Ohio, United States

Cleveland, Ohio

Cleveland, Ohio, United States

Key Dates

Start Date

January 6, 2020

Primary Completion Date

October 1, 2024

Completion Date

October 1, 2024

Last Updated

November 21, 2025

Enrollment

304

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Tavapadon

DRUG

Placebo

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients