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

NCT04201093 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CVL-751-PD-0012019-002949-38
• Study Type: interventional
• Target: 529
• Locations: 12 countries
• Sites: 77

Brief Summary

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

Parkinson Disease

Keywords

Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the MDS-UPDRS Parts II and III Combined Score

  The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.

  Week 26

Secondary Outcomes (12)

• Change From Baseline in the MDS-UPDRS Part II Score

  Week 26

• Percentage of Responders With a Score of "Much Improved" or "Very Much Improved" on PGIC

  Week 26

• Change From Baseline in the MDS-UPDRS Parts II and III Combined Score

  Week 5, 8, 11, 14, 18, 22, 26, and 27

• Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score

  Week 5, 8, 11, 14, 18, 22, 26, and 27

• Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score

  Week 5, 8, 11, 14, 18, 22, 26, and 27

Study Arms (3)

Tavapadon 5 mg

EXPERIMENTAL

Participants will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks.

Drug: Tavapadon

Tavapadon 15 mg

EXPERIMENTAL

Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.

Drug: Tavapadon

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

Drug: Placebo

Interventions

Tavapadon DRUG

Participants will be randomized to receive tavapadon 5mg tablet once daily orally for 27 weeks.

Also known as: PF-06649751, CVL-751

Tavapadon 5 mg

Placebo DRUG

Participants will receive placebo matching to tavapadon QD orally for 27 weeks.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• AbbVie: lead

Study Sites (77)

Birmingham, Alabama

Birmingham, Alabama, 35233, United States

Location

Little Rock, Arkansas

Little Rock, Arkansas, 72205, United States

Location

Fountain Valley, California

Fountain Valley, California, 92708, United States

Location

Los Angeles, California

Los Angeles, California, 90048, United States

Location

Pasadena, California

Pasadena, California, 91105, United States

Location

Englewood, Colorado

Englewood, Colorado, 80113, United States

Location

Adventura, Florida

Adventura, Florida, 33180, United States

Location

Boca Raton, Florida

Boca Raton, Florida, 33486, United States

Location

Tampa, Florida

Tampa, Florida, 33613, United States

Location

Augusta, Georgia

Augusta, Georgia, 30912, United States

Location

Savannah, Georgia

Savannah, Georgia, 31406, United States

Location

Chicago, Illinois

Chicago, Illinois, 60612, United States

Location

Kansas City, Kansas

Kansas City, Kansas, 66160, United States

Location

Scarborough, Maine

Scarborough, Maine, 04074, United States

Location

Boston, Massachusetts

Boston, Massachusetts, 02215, United States

Location

East Lansing, Michigan

East Lansing, Michigan, 48824, United States

Location

Las Vegas, Nevada

Las Vegas, Nevada, 89106, United States

Location

Asheville, North Carolina

Asheville, North Carolina, 28806, United States

Location

Durham, North Carolina

Durham, North Carolina, 27705, United States

Location

Columbus, Ohio

Columbus, Ohio, 43221, United States

Location

Toledo, Ohio

Toledo, Ohio, 43614, United States

Location

Philadelphia, Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Georgetown, Texas

Georgetown, Texas, 78628, United States

Location

Houston, Texas

Houston, Texas, 77030, United States

Location

Lubbock, Texas

Lubbock, Texas, 79410, United States

Location

Burlington, Vermont

Burlington, Vermont, 05401, United States

Location

Virginia Beach, Virginia

Virginia Beach, Virginia, 23456, United States

Location

Erina, New South Wales

Erina, New South Wales, 02250, Australia

Location

Woolloongabba, Queensland

Woolloongabba, Queensland, 4102, Australia

Location

Parkville, Victoria

Parkville, Victoria, 3050, Australia

Location

Medical center VITA1, Pleven

Pleven, 5800, Bulgaria

Location

Pleven, Bulgaria

Pleven, 5800, Bulgaria

Location

Pleven

Pleven, 5800, Bulgaria

Location

Multiprofile Hospital, Sofia

Sofia, 1113, Bulgaria

Location

Sofia

Sofia, 1142, Bulgaria

Location

Sofia

Sofia, 1407, Bulgaria

Location

DCC Neoclinic

Sofia, 1408, Bulgaria

Location

Sofia

Sofia, 1431, Bulgaria

Location

Ottawa, Ontario

Ottawa, Ontario, K1Y4E9, Canada

Location

Toronto, Ontario

Toronto, Ontario, M5T 2S8, Canada

Location

Poliklinika, Chocen,

Choceň, Chocen, 565 01, Czechia

Location

Prague,

Prague, 100 00, Czechia

Location

Rychnov nad Kněžnou

Rychnov nad Kněžnou, 516 01, Czechia

Location

Creteil

Créteil, Creteil, 94010, France

Location

Boulevard Pinel, Bron

Bron, 69500, France

Location

Grenoble cedex

Grenoble, 38043, France

Location

Nancy, France

Nancy, 54035, France

Location

Nîmes cedex

Nîmes, 30029, France

Location

Muenster

Münster, Muenster, 48149, Germany

Location

Bad Homburg

Bad Homburg, 61348, Germany

Location

Duesseldorf,

Düsseldorf, 40225, Germany

Location

Haag in Oberbayern

Haag in Oberbayern, 83527, Germany

Location

Stadtroda

Stadtroda, 07646, Germany

Location

Haifa

Haifa, 3109601, Israel

Location

Petah Tiqva

Petah Tikva, 49100, Israel

Location

Ramat Gan

Ramat Gan, 5265601, Israel

Location

Tel Aviv

Tel Aviv, 6100000, Israel

Location

Milano

Milan, 20126, Italy

Location

Padova

Padua, 35128, Italy

Location

Pisa

Pisa, 56126, Italy

Location

Rome

Rome, 00163, Italy

Location

Rome

Rome, 00179, Italy

Location

Kraków

Krakow, 30-510, Poland

Location

Singua

Warsaw, 02-777, Poland

Location

Lodz

Lodz, Łódź Voivodeship, 90-640, Poland

Location

Elche

Elche, Alicante, 03203, Spain

Location

Barcelona

Barcelona, 08041, Spain

Location

Barcelona

Barcelona, 08190, Spain

Location

Madrid

Madrid, 28006, Spain

Location

Madrid, Spain

Madrid, 28036, Spain

Location

Madrid, Spain

Madrid, 28922, Spain

Location

Terrassa

Terrassa, 08222, Spain

Location

Valencia

Valencia, 46026, Spain

Location

Zaporiizhzhya

Zaporizhzhya, Zaporiizhzhya, 69600, Ukraine

Location

Zaporozhya

Zaporizhzhya, Zaporozhya, 69035, Ukraine

Location

Dnipro

Dnipro, 49027, Ukraine

Location

Kharkiv

Kharkiv, 61068, Ukraine

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Synucleinopathies

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC., MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: December 13, 2019
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8); US (27); CA (2); DE (5); CZ (3); FR (5); PL (3); IT (5); UA (4); AU (3); BU (8); IL (4)