New drug tavapadon tested to ease Parkinson's symptoms

NCT ID NCT04223193

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether tavapadon, a daily pill, can improve movement and daily activities in people with early Parkinson's disease. Over 300 participants took either tavapadon or a placebo for 27 weeks. The study measured changes in motor function and daily living skills using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tavapadon
What this could lead to: If successful, tavapadon could offer a new treatment option to help control motor symptoms in early Parkinson's disease.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. Tavapadon may not prove significantly better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

304 people

The number who actually took part.

Started

Jan 2020

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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. Key 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. * Participants with a history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical intervention; second- or third-degree atrioventricular block; sick sinus syndrome; severe or unstable angina; or congestive heart failure within the last 12 months. A recent (less than or equal to \[\<=\] 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control. * Participants with a history of neuroleptic malignant syndrome. * Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration). * Participants with a positive urine drug screen for illicit drugs are excluded and may not be retested or rescreened. Participants with a positive urine drug screen resulting from use of marijuana (any Tetrahydrocannabinol \[THC\]-containing product), prescription, or over-the-counter medications or products that, in the investigator's documented opinion, do not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor. * Participants with a Montreal Cognitive Assessment (MoCA) score \<26. * Participants with clinically significant orthostatic hypotension (eg, syncope). * Participants with a 12-lead ECG demonstrating a QTcF interval \>450 msec. * Participants with moderate or severe renal impairment (creatinine clearance as estimated by Cockcroft-Gault formula \<30 mL/min or on dialysis). * Participants with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary: * Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \>=3 × Upper Limit Normal (ULN). * Total bilirubin \>=1.5 × ULN. Participants with a history of Gilbert's syndrome may be eligible provided they have a value \<ULN for direct bilirubin. * Participants with other abnormal laboratory test results, vital sign results, or ECG findings unless, in the judgment of the investigator, the findings are not medically significant and would not impact the safety of the participants or the interpretation of the trial results.

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Conditions

The condition(s) this trial relates to.

brain disorder central nervous system disorder movement disorder nervous system disorder neurodegenerative disease Parkinson disease parkinsonian disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

Albany, New York

Albany, New York, 12208, United States
Barcelona

Barcelona, Barcelona, 08035, Spain
Belgrade

Belgrade, Belgrade, 11000, Serbia
Berlin

Berlin, State of Berlin, 12163, Germany
Boca Raton, Florida

Boca Raton, Florida, 33487, United States
Bochum

Bochum, Bochum, 44791, Germany
Boston Neuro Research Center

North Dartmouth, Massachusetts, 02747, United States
Budapest

Budapest, Budapest, 1135, Hungary
Cassino

Cassino, Cassino, 03043, Italy
Centrum Medyczne Hope Clinic Sebastian Szklener

Lublin, 20-701, Poland
Centrum Medyczne NEUROMED

Bydgoszcz, 85-163, Poland
Cincinnati, Ohio

Cincinnati, Ohio, 45212, United States
Cleveland, Ohio

Cleveland, Ohio, 44195, United States
Cracow

Krakow, Cracow, 31-505, Poland
Cypress, Texas

Cypress, Texas, 77429, United States
Dongdaemun-gu, Seoul

Seoul, Dongdaemun-gu, 02447, South Korea
Fresno, California

Fresno, California, 93710, United States
Gera

Gera, Gera, 07551, Germany
Haeundae-gu, Busan

Busan, Haeundae-gu, 48108, South Korea
Houston, Texas

Houston, Texas, 77030, United States
Katowice

Katowice, Katowice, 40-097, Poland
Khlong Luang, Pathum Thani

Khlong Luang, Changwat Pathum Thani, 12120, Thailand
Kiev

Kiev, Kyiv City, 04114, Ukraine
Kirkland, Washington

Kirkland, Washington, 98034, United States
Lubbock, Texas

Lubbock, Texas, 79410, United States
Lviv

Lviv, Lviv Oblast, 79010, Ukraine
Macquarie Park, New South Wales

Sydney, New South Wales, 2109, Australia
Maitland, Florida

Maitland, Florida, 32751, United States
Marseille, France

Marseille, France, 13385, France
Memphis, Tennessee

Memphis, Tennessee, 38157, United States
Milano

Milan, Milano, 20132, Italy
Muenchen

München, Muenchen, 81377, Germany
Móstoles, Madrid

Madrid, Madrid, 28938, Spain
Nai Muang, Ubon Ratchathani

Nai Muang, Changwat Ubon Ratchathani, 34000, Thailand
Nantes CEDEX 1

Nantes, Nantes, 44093, France
Ocala, Florida

Ocala, Florida, 34470, United States
Pecs

Pécs, Hungary, 7623, Hungary
Ratchathewi, Bangkok

Ratchathewi, Bangkok, 10400, Thailand
Richmond, Virginia

Richmond, Virginia, 23229, United States
Richmond, Virginia

Richmond, Virginia, 23233, United States
Rome

Rome, Rome, 00133, Italy
Round Rock, Texas

Round Rock, Texas, 78681, United States
Rozzano Milano

Rozzano, 20089, Italy
Siemianowice Slaskie

Siemianowice Śląskie, Siemianowice Slaskie, 41-100, Poland
Songpa-gu, Seoul

Seoul, Songpa-gu, 05505, South Korea
Syracuse, New York

Syracuse, New York, 13210, United States
Tatabanya

Tatabánya, 2800, Hungary
Torino

Torino, 10126, Italy
Toulouse Cedex 9

Toulouse, Toulouse, 31059, France
Vinnitsa

Vinnitsa, Vinnitsa, 21050, Ukraine
Winter Park, Florida

Winter Park, Florida, 32792, United States
Zhongzheng, Taipei

Zhongzheng, Taipei, 100225, Taiwan
Zhongzheng, Taipei

Zhongzheng, Taipei, 112062, Taiwan

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