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Completed · registry status

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

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Testing a treatment or activity · Study reference: NCT04201093

The registry title is shown while an English plain-language introduction is prepared. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

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Results reported

Start (reported actual date)
2019-12-13
Main measurements finished (reported actual date)
2024-06-28
Study finished (reported actual date)
2024-06-28

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry ↗

Changes we have recorded
  • 2026-10-11 — completed

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

Fixed-Dose Tavapadon for Early Parkinson Disease
Listed by the registry as research derived from the study · 2026

Participation rules recorded for this study

Ages 40 years to 80 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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 naïve or have a history of prior incidental treatment with dopaminergic agents (including Levodopa \[L-Dopa\] and dopamine receptor agonist medications) for \<3 months in total but not within 2 months of the Baseline Visit. Prior and concurrent use of monoamine oxidase B (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 (i.e, 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 Columbia-Suicide Severity Rating Scale (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.
Full study name & original research details

Official study title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)

Short title used by the registry

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

Original description

The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Tavapadon; Placebo; Tavapadon
Phases
PHASE3
Sponsor
AbbVie
Start date reported by registry
2019-12-13 (actual)

Registry updated: 2025-07-28 · Status last verified by the registry submitter: 2025-07

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Birmingham, Alabama

Birmingham, Alabama, United States

Status not reported

Little Rock, Arkansas

Little Rock, Arkansas, United States

Status not reported

Fountain Valley, California

Fountain Valley, California, United States

Status not reported

Los Angeles, California

Los Angeles, California, United States

Status not reported

Pasadena, California

Pasadena, California, United States

Status not reported

Englewood, Colorado

Englewood, Colorado, United States

Status not reported

Adventura, Florida

Adventura, Florida, United States

Status not reported

Boca Raton, Florida

Boca Raton, Florida, United States

Status not reported

Tampa, Florida

Tampa, Florida, United States

Status not reported

Augusta, Georgia

Augusta, Georgia, United States

Status not reported

Savannah, Georgia

Savannah, Georgia, United States

Status not reported

Chicago, Illinois

Chicago, Illinois, United States

Status not reported

Kansas City, Kansas

Kansas City, Kansas, United States

Status not reported

Scarborough, Maine

Scarborough, Maine, United States

Status not reported

Boston, Massachusetts

Boston, Massachusetts, United States

Status not reported

East Lansing, Michigan

East Lansing, Michigan, United States

Status not reported

Las Vegas, Nevada

Las Vegas, Nevada, United States

Status not reported

Asheville, North Carolina

Asheville, North Carolina, United States

Status not reported

Durham, North Carolina

Durham, North Carolina, United States

Status not reported

Columbus, Ohio

Columbus, Ohio, United States

Status not reported

Toledo, Ohio

Toledo, Ohio, United States

Status not reported

Philadelphia, Pennsylvania

Philadelphia, Pennsylvania, United States

Status not reported

Georgetown, Texas

Georgetown, Texas, United States

Status not reported

Houston, Texas

Houston, Texas, United States

Status not reported

Lubbock, Texas

Lubbock, Texas, United States

Status not reported

Burlington, Vermont

Burlington, Vermont, United States

Status not reported

Virginia Beach, Virginia

Virginia Beach, Virginia, United States

Status not reported

Erina, New South Wales

Erina, New South Wales, Australia

Status not reported

Woolloongabba, Queensland

Woolloongabba, Queensland, Australia

Status not reported

Parkville, Victoria

Parkville, Victoria, Australia

Status not reported

Medical center VITA1, Pleven

Pleven, Bulgaria

Status not reported

Pleven, Bulgaria

Pleven, Bulgaria

Status not reported

Pleven

Pleven, Bulgaria

Status not reported

Multiprofile Hospital, Sofia

Sofia, Bulgaria

Status not reported

Sofia

Sofia, Bulgaria

Status not reported

DCC Neoclinic

Sofia, Bulgaria

Status not reported

Ottawa, Ontario

Ottawa, Ontario, Canada

Status not reported

Toronto, Ontario

Toronto, Ontario, Canada

Status not reported

Poliklinika, Chocen,

Choceň, Chocen, Czechia

Status not reported

Prague,

Prague, Czechia

Status not reported

Rychnov nad Kněžnou

Rychnov nad Kněžnou, Czechia

Status not reported

Creteil

Créteil, Creteil, France

Status not reported

Boulevard Pinel, Bron

Bron, France

Status not reported

Grenoble cedex

Grenoble, France

Status not reported

Nancy, France

Nancy, France

Status not reported

Nîmes cedex

Nîmes, France

Status not reported

Muenster

Münster, Muenster, Germany

Status not reported

Bad Homburg

Bad Homburg, Germany

Status not reported

Duesseldorf,

Düsseldorf, Germany

Status not reported

Haag in Oberbayern

Haag in Oberbayern, Germany

Status not reported

Stadtroda

Stadtroda, Germany

Status not reported

Haifa

Haifa, Israel

Status not reported

Petah Tiqva

Petah Tikva, Israel

Status not reported

Ramat Gan

Ramat Gan, Israel

Status not reported

Tel Aviv

Tel Aviv, Israel

Status not reported

Milano

Milan, Italy

Status not reported

Padova

Padova, Italy

Status not reported

Pisa

Pisa, Italy

Status not reported

Rome

Rome, Italy

Status not reported

Kraków

Krakow, Poland

Status not reported

Singua

Warsaw, Poland

Status not reported

Lodz

Lodz, Łódź Voivodeship, Poland

Status not reported

Elche

Elche, Alicante, Spain

Status not reported

Barcelona

Barcelona, Spain

Status not reported

Madrid

Madrid, Spain

Status not reported

Madrid, Spain

Madrid, Spain

Status not reported

Terrassa

Terrassa, Spain

Status not reported

Valencia

Valencia, Spain

Status not reported

Zaporiizhzhya

Zaporizhzhya, Zaporiizhzhya, Ukraine

Status not reported

Zaporozhya

Zaporizhzhya, Zaporozhya, Ukraine

Status not reported

Dnipro

Dnipro, Ukraine

Status not reported

Kharkiv

Kharkiv, Ukraine

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.