Open-label Trial in Parkinson's Disease (PD)

NCT04760769 | Completed Phase 3 FDA Drug

• 2 other identifiers: CVL-751-PD-0042019-002952-17
• Study Type: interventional
• Target: 992
• Locations: 14 countries
• Sites: 140

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of long-term administration 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 (10)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, Vital Signs, Physical and Neurological evaluations and ECGs will be reported as TEAEs.

  62 Weeks

• Number of Participants Who Discontinued Study Treatment

  A participant may discontinue the study treatment due to any of the following reasons: adverse event, death, worsening of PD symptoms to such an extent that, in the judgement of the investigator, the participant requires additional anti-PD medications, treatment with a prohibited concomitant medication, noncompliance with the trial schedule or procedures, withdrawal of consent, pregnancy, investigator discretion.

  62 Weeks

• Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS)

  QUIP-RS is a global screening instrument that assesses impulse control disorders (ICDs) and related disorders (punding, hobbyism, and dopamine dysregulation syndrome) in participants with PD. The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 \[0 means "never" and 4 means "very often"\] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112.

  58 Weeks

• Epworth Sleepiness Scale (ESS)

  ESS is a scale that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated as 0 = would never nod off, 1 = slight chance of nodding off, 2 = moderate chance of nodding off, or 3 = high chance of nodding off. A score greater than or equal to (\> =) 10 indicates that the participant may need to get more sleep, improve sleep practices, or seek medical attention to determine why he or she is sleepy.

  58 Weeks

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).

  60 Weeks

• Study Medication Withdrawal Questionnaire (SMWQ)

  SMWQ is a questionnaire to assess withdrawal symptoms subsequent to completion of dosing with Investigational medicinal product (IMP). The SMWQ is a modification of the Amphetamine Withdrawal Questionnaire, in which the first question "Have you been craving amphetamine or methamphetamine?" is replaced with "Have you been craving the trial medication?" This change is intended to prevent bias by implying that the trial medication might be an amphetamine or amphetamine-like stimulant when presented with the survey. Participants will complete the SMWQ onsite when they are at a designated trial visit; on days when the participant is not onsite, they will complete the SMWQ remotely.

  60 Weeks

• Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III

  The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Part I, non-motor aspects of experiences of daily living, comprises 13 items, 6 of which are rated by the physician (Part IA) and 7 of which are rated by the participant (Part IB). Part II, motor aspects of experiences of daily living, comprises 13 items that are rated by the participant. Part III, motor examination, comprises 18 items that are assessed by the investigator (resulting in 33 scores by location and lateralization). Part IV, motor complications, comprises 6 item (3 items for dyskinesia and 3 items for fluctuation) and requires the physician to use historical and objective information to assess dyskinesia and motor fluctuations. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Change from baseline in MDS-UPDRS parts I, II and III combined score will be assessed.

  60 Weeks

• Change From Baseline in the Hauser diary

  The Hauser diary (Hauser et al, 2000) assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep.

  58 Weeks

• Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index

  EQ-5D-5L is a survey instrument used for participant-reported outcome that measures health in 5 dimensions. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels of perceived problems (1 = no problem, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = extreme problems). Participant selects an answer for each of 5 dimensions considering the response that best matches his/her health "today". The digits for the 5 dimensions are combined into a 5-digit number that describes the participant's health state.

  Baseline (Day 1), Weeks 32 and 58

• Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS)

  EQ-5D-5L VAS is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. The EQ-5D-5L VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).

  Baseline (Day 1), Weeks 32 and 58

Study Arms (1)

Tavapadon

EXPERIMENTAL

Participants will receive a Tavapadon tablet at a dose of 5 milligrams (mg) to 15 mg once daily (QD) orally during 58-week treatment period.

Drug: Tavapadon

Interventions

Tavapadon DRUG

Participants will receive Tavapadon at a dose of (5 to 15) mg QD, orally during a 58-week treatment period.

Also known as: PF-06649751, CVL-751

Tavapadon

Eligibility Criteria

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

You may qualify if:

• Participants who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 (NCT04201093) or Trial CVL-751 PD-003 (NCT04542499) or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 (NCT04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover participants from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
• 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 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.
• Participant who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial.

You may not qualify if:

• Rollover participants are excluded from the trial if any of the following met:
• Participants who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial
• 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 who had previously been enrolled in this open-label trial and had subsequently withdrawn.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (140)

Birmingham, Alabama

Birmingham, Alabama, 35233, United States

Location

Pheonix, Arizona

Phoenix, Arizona, 85004, United States

Location

Little Rock, Arkansas

Little Rock, Arkansas, 72205, United States

Location

Fountain Valley, California

Fountain Valley, California, 92708, United States

Location

Fresno, California

Fresno, California, 93710, United States

Location

Los Angeles, California

Los Angeles, California, 90048, United States

Location

Pasadena, California

Pasadena, California, 91105, United States

Location

Reseda, California

Reseda, California, 91335, United States

Location

Englewood, Colorado

Englewood, Colorado, 80113, United States

Location

Florida, United States

Adventura, Florida, 33180, United States

Location

Boca Raton, Florida

Boca Raton, Florida, 33486, United States

Location

Coral Springs, Florida

Coral Springs, Florida, 33067, United States

Location

Maitland, Florida

Maitland, Florida, 32751, United States

Location

Naples, Florida

Naples, Florida, 34102, United States

Location

Ocala, Florida

Ocala, Florida, 34470, United States

Location

Port Charlotte, Florida

Port Charlotte, Florida, 33980, United States

Location

Port Orange, Florida

Port Orange, Florida, 32127, United States

Location

Tampa, Florida

Tampa, Florida, 33615, United States

Location

Winter Park, Florida

Winter Park, Florida, 32792, United States

Location

Augusta, Georgia

Augusta, Georgia, 30912, United States

Location

Chicago, Illinois

Chicago, Illinois, 60612, United States

Location

Winfield, Illinois

Winfield, Illinois, 60190, United States

Location

Kansas City

Kansas City, Kansas, 66160, United States

Location

Lexington, Kentucky

Lexington, Kentucky, 40536, United States

Location

Scarborough, Maine

Scarborough, Maine, 04074, United States

Location

Boston, Massachusettes

Boston, Massachusetts, 02215, United States

Location

Lawrence, Massachusetts

Lawrence, Massachusetts, 01843, United States

Location

East Lansing, Michigan

East Lansing, Michigan, 48824, United States

Location

West Bloomfield

West Bloomfield, Michigan, 48322, United States

Location

Las Vegas, Nevada

Las Vegas, Nevada, 89106, United States

Location

Camden, New Jersey

Camden, New Jersey, 08103, United States

Location

Albany, New York

Albany, New York, 12208, United States

Location

Syracuse, New York

Syracuse, New York, 13210, United States

Location

Asheville, North Carolina

Asheville, North Carolina, 28806, United States

Location

Durham, North Carolina

Durham, North Carolina, 27705, United States

Location

Cincinnati, Ohio

Cincinnati, Ohio, 45212, United States

Location

Cleveland, Ohio

Cleveland, Ohio, 44195, United States

Location

Columbus, Ohio

Columbus, Ohio, 43221, United States

Location

Dayton, Ohio

Dayton, Ohio, 45459, United States

Location

Toledo, Ohio

Toledo, Ohio, 43614, United States

Location

Philadelphia, Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Memphis, Tennessee

Memphis, Tennessee, 38157, 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

Round Rock, Texas

Round Rock, Texas, 78681, United States

Location

Burlington, Vermont

Burlington, Vermont, 05401, United States

Location

Richmond, Virginia

Richmond, Virginia, 23229, United States

Location

Richmond, Virginia

Richmond, Virginia, 23233, United States

Location

Virginia Beach, Virginia

Virginia Beach, Virginia, 23456, United States

Location

Kirkland, Washington

Kirkland, Washington, 98034, United States

Location

Spokane, Washington

Spokane, Washington, 99202, United States

Location

Erina, New South Wales

Erina, New South Wales, 2250, Australia

Location

Kogarah

Kogarah, New South Wales, 2217, Australia

Location

Macquarie Park, New South Wales

Sydney, New South Wales, 2109, Australia

Location

Woolloongabba, Queensland

Woolloongabba, Queensland, 4102, Australia

Location

Clayton, Victoria

Clayton, Victoria, 3168, 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

Sofia

Sofia, 1431, Bulgaria

Location

Ottawa, Ontario

Ottawa, Ontario, K1Y4E9, Canada

Location

Toronto, Ontario

Toronto, Ontario, M5T 2S8, Canada

Location

Chocen

Choceň, Chocen, 56501, Czechia

Location

Prague, Czech Republic

Prague, Czech Republic, 150 00, Czechia

Location

Prague,

Prague, 100 00, Czechia

Location

Prague,

Prague, 160 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

Nancy, 54035, France

Location

Nîmes cedex 09

Nîmes, 30029, France

Location

Strasbourg

Strasbourg, 67098, France

Location

Toulouse Cedex 9

Toulouse, 31059, France

Location

Muenster

Münster, Muenster, 48149, Germany

Location

Bad Homburg

Bad Homburg, 61348, Germany

Location

Berlin

Berlin, 12163, Germany

Location

Bochum

Bochum, 44791, Germany

Location

Gera

Gera, D-07551, Germany

Location

Haag in Oberbayern

Haag in Oberbayern, 83527, Germany

Location

Klinikum rechts der Isar der TU München

Munich, 81675, Germany

Location

Muenchen

München, 81377, Germany

Location

Stadtroda

Stadtroda, 07646, Germany

Location

Budapest

Budapest, 1135, Hungary

Location

Pecs

Pécs, 7623, Hungary

Location

Tatabanya

Tatabánya, 2800, Hungary

Location

Haifa

Haifa, 3109601, Israel

Location

Petah Tiqva

Petah Tikva, 49100, Israel

Location

Ramat Gan

Ramat Gan, 5265601, Israel

Location

Shoham

Shoham, 6083531, Israel

Location

Tel Aviv

Tel Aviv, 6100000, Israel

Location

Ancona

Ancona, 60126, Italy

Location

Cassino

Cassino, 03043, Italy

Location

Milano, Italy

Milan, 20126, Italy

Location

Milano

Milan, 20132, Italy

Location

Padova

Padua, 35128, Italy

Location

Pisa

Pisa, 56126, Italy

Location

Rome

Rome, 00133, Italy

Location

Rome

Rome, 00163, Italy

Location

Rome

Rome, 00179, Italy

Location

Torino

Torino, 10126, Italy

Location

Cracow

Krakow, Cracow, 31-505, Poland

Location

Siemianowice Slaskie

Siemianowice Śląskie, Siemianowice Slaskie, 41-100, Poland

Location

Centrum Medyczne NEUROMED

Bydgoszcz, 85-163, Poland

Location

Katowice

Katowice, 40-097, Poland

Location

Katowice

Katowice, 40-123, Poland

Location

Kraków

Krakow, 30-510, Poland

Location

Krakow

Krakow, 30-539, Poland

Location

Krakow

Krakow, 30-721, Poland

Location

Lublin

Lublin, 20-016, Poland

Location

Centrum Medyczne Hope Clinic Sebastian Szklener

Lublin, 20-701, Poland

Location

Warsaw

Warsaw, 01-868, Poland

Location

Singua

Warsaw, 02-777, Poland

Location

Belgrade, Serbia

Belgrade, 11000, Serbia

Location

Belgrade,

Belgrade, 11000, Serbia

Location

Belgrade

Belgrade, 11000, Serbia

Location

Belgrade, Kragujevac

Belgrade, 11060, Serbia

Location

Elche

Elche, Alicante, 03203, Spain

Location

Barcelona

Barcelona, 08035, Spain

Location

Barcelona

Barcelona, 08041, Spain

Location

Sant Cugat del Vallés Barcelona

Barcelona, 08190, Spain

Location

San Sebastian

Donostia / San Sebastian, 20009, Spain

Location

Madrid

Madrid, 28006, Spain

Location

Móstoles, Madrid

Madrid, 28938, Spain

Location

Pamplona

Pamplona, 31008, Spain

Location

Sevilla

Seville, 41013, Spain

Location

Terrassa

Terrassa, 08222, Spain

Location

Valencia

Valencia, 46026, Spain

Location

Zaporiizhzhya

Zaporizhzhya, Zaporiizhzhya, 69600, Ukraine

Location

Zaporozhya

Zaporizhzhya, Zaporozhya, 69000, Ukraine

Location

Dnipro

Dnipro, 49005, Ukraine

Location

Dnipro

Dnipro, 49027, Ukraine

Location

Lviv

Lviv, Ukraine

Location

Vinnitsa

Vinnitsa, 21050, Ukraine

Location

Medical Center, Zaporizhzhya

Zaporizhzhya, 69035, 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

Study Officials

• ABBVIE Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 18, 2021
• Study Start: February 24, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (11); UA (7); DE (9); AU (6); FR (7); CZ (5); US (52); BU (7); IL (5); CA (2); IT (10); HU (3); PL (12); SE (4)