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

NCT04223193 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CVL-751-PD-0022019-002950-22
• Study Type: interventional
• Target: 304
• Locations: 13 countries
• Sites: 53

Brief 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.

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 Movement Disorder Society - Unified Parkinson's Disease Rating Scale (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 "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (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 (2)

Tavapadon

EXPERIMENTAL

Participants will receive tavapadon tablet titrated up to 15 milligram (mg) once daily (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 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks.

Also known as: PF-06649751, CVL-751

Tavapadon

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 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.

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 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 (53)

Fresno, California

Fresno, California, 93710, United States

Location

Boca Raton, Florida

Boca Raton, Florida, 33487, United States

Location

Maitland, Florida

Maitland, Florida, 32751, United States

Location

Ocala, Florida

Ocala, Florida, 34470, United States

Location

Winter Park, Florida

Winter Park, Florida, 32792, United States

Location

Boston Neuro Research Center

North Dartmouth, Massachusetts, 02747, United States

Location

Albany, New York

Albany, New York, 12208, United States

Location

Syracuse, New York

Syracuse, New York, 13210, United States

Location

Cincinnati, Ohio

Cincinnati, Ohio, 45212, United States

Location

Cleveland, Ohio

Cleveland, Ohio, 44195, United States

Location

Memphis, Tennessee

Memphis, Tennessee, 38157, United States

Location

Cypress, Texas

Cypress, Texas, 77429, United States

Location

Houston, Texas

Houston, Texas, 77030, United States

Location

Lubbock, Texas

Lubbock, Texas, 79410, United States

Location

Round Rock, Texas

Round Rock, Texas, 78681, United States

Location

Richmond, Virginia

Richmond, Virginia, 23229, United States

Location

Richmond, Virginia

Richmond, Virginia, 23233, United States

Location

Kirkland, Washington

Kirkland, Washington, 98034, United States

Location

Macquarie Park, New South Wales

Sydney, New South Wales, 2109, Australia

Location

Marseille, France

Marseille, France, 13385, France

Location

Nantes CEDEX 1

Nantes, Nantes, 44093, France

Location

Toulouse Cedex 9

Toulouse, Toulouse, 31059, France

Location

Bochum

Bochum, Bochum, 44791, Germany

Location

Gera

Gera, Gera, 07551, Germany

Location

Muenchen

München, Muenchen, 81377, Germany

Location

Berlin

Berlin, State of Berlin, 12163, Germany

Location

Budapest

Budapest, Budapest, 1135, Hungary

Location

Pecs

Pécs, Hungary, 7623, Hungary

Location

Tatabanya

Tatabánya, 2800, Hungary

Location

Cassino

Cassino, Cassino, 03043, Italy

Location

Milano

Milan, Milano, 20132, Italy

Location

Rome

Rome, Rome, 00133, Italy

Location

Rozzano Milano

Rozzano, 20089, Italy

Location

Torino

Torino, 10126, Italy

Location

Cracow

Krakow, Cracow, 31-505, Poland

Location

Katowice

Katowice, Katowice, 40-097, Poland

Location

Siemianowice Slaskie

Siemianowice Śląskie, Siemianowice Slaskie, 41-100, Poland

Location

Centrum Medyczne NEUROMED

Bydgoszcz, 85-163, Poland

Location

Centrum Medyczne Hope Clinic Sebastian Szklener

Lublin, 20-701, Poland

Location

Belgrade

Belgrade, Belgrade, 11000, Serbia

Location

Dongdaemun-gu, Seoul

Seoul, Dongdaemun-gu, 02447, South Korea

Location

Haeundae-gu, Busan

Busan, Haeundae-gu, 48108, South Korea

Location

Songpa-gu, Seoul

Seoul, Songpa-gu, 05505, South Korea

Location

Barcelona

Barcelona, Barcelona, 08035, Spain

Location

Móstoles, Madrid

Madrid, Madrid, 28938, Spain

Location

Zhongzheng, Taipei

Zhongzheng, Taipei, 100225, Taiwan

Location

Zhongzheng, Taipei

Zhongzheng, Taipei, 112062, Taiwan

Location

Ratchathewi, Bangkok

Ratchathewi, Bangkok, 10400, Thailand

Location

Khlong Luang, Pathum Thani

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Nai Muang, Ubon Ratchathani

Nai Muang, Changwat Ubon Ratchathani, 34000, Thailand

Location

Kiev

Kiev, Kyiv City, 04114, Ukraine

Location

Lviv

Lviv, Lviv Oblast, 79010, Ukraine

Location

Vinnitsa

Vinnitsa, Vinnitsa, 21050, 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.

  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: January 7, 2020
• First Posted: January 10, 2020
• Study Start: January 6, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); ES (2); TH (3); HU (3); PL (5); US (18); AU (1); FR (3); TW (2); UA (3); KR (3); DE (4); IT (5)