Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)

NCT ID: NCT04542499

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 507 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2024-02-15

Brief Summary

The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tavapadon

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

Group Type: EXPERIMENTAL

Tavapadon

Intervention Type: DRUG

Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Tavapadon

Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

PF-06649751; CVL-751

Eligibility Criteria

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 this protocol.
• Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry.
• Participants with modified Hoehn and Yahr stage 2, 2.5, or 3 in the "on" state.
• Participants with a good response to levodopa (L- Dopa) in the judgment of the investigator.
• Participants who return a completed self-reported home diary for motor function status (Hauser diary) during the screening period (after diary training and concordance testing has occurred), with recordings for 2 consecutive days (ie, 2 consecutive 24-hour periods) showing at least 2 and half hours of "off" time on each of the 2 days.
• Participants who are on a stable dose of L-Dopa for at least 4 weeks prior to screening and are taking a minimum total daily dose of 400 milligram (mg) divided in at least 4 doses per day of standard carbidopa/levodopa or divided in at least 3 doses per day of extended-release carbidopa/levodopa capsules. The carbidopa/levodopa dose and frequency must be maintained for the duration of the trial.
• Prior and concurrent use of catechol-O-methyltransferase (COMT) inhibitors, monoamine oxidaseB (MAO-B) inhibitors, amantadine, istradefylline or anticholinergic drugs are permitted if the use was initiated greater than (>) 90 days before the baseline visit and the dosage will remain stable for the duration of the trial (ie, no change in the COMT,MAO-B inhibitor, amantadine, istradefylline or anticholinergic dose is permitted during the trial).

Exclusion Criteria

• Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear 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 last6 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 5C-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 6months (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 12months. 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-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 aQTcF 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Pheonix, Arizona

Phoenix, Arizona, United States

Little Rock, Arkansas

Little Rock, Arkansas, United States

Fountain Valley, California

Fountain Valley, California, United States

Fresno, California

Fresno, California, United States

Long beach, California

Long Beach, California, United States

Los Angeles, California

Los Angeles, California, United States

Pasadena, California

Pasadena, California, United States

Reseda, California

Reseda, California, United States

Denver, Colorado

Denver, Colorado, United States

Englewood, Colorado

Englewood, Colorado, United States

Adventura, Florida

Adventura, Florida, United States

Atlantis, Florida

Atlantis, Florida, United States

Boca Raton, Florida

Boca Raton, Florida, United States

Boca Raton, Florida

Boca Raton, Florida, United States

Coral Springs, Florida

Coral Springs, Florida, United States

Hallandale Beach, Florida

Hallandale, Florida, United States

Maitland, Florida

Maitland, Florida, United States

Ocala, Florida

Ocala, Florida, United States

Port Charlotte, Florida

Port Charlotte, Florida, United States

Port Orange, Florida

Port Orange, Florida, United States

Tampa, Florida

Tampa, Florida, United States

Winter Park, Florida

Winter Park, Florida, United States

Augusta, Georgia

Augusta, Georgia, United States

Chicago, Illinois

Chicago, Illinois, United States

Elk Grove Village, Illinois

Elk Grove Village, Illinois, United States

Kansas City, Kansas

Kansas City, Kansas, United States

Lexington, Kentucky

Lexington, Kentucky, United States

Scarborough, Maine

Scarborough, Maine, United States

Boston, Massachusettes

Boston, Massachusetts, United States

Boston Neuro Research Center

North Dartmouth, Massachusetts, United States

Farmington Hills, Michigan

Farmington Hills, Michigan, United States

West Bloomfield, Michigan

West Bloomfield, Michigan, United States

Saint Louis, Missouri

St Louis, Missouri, United States

Las Vegas, Nevada

Las Vegas, Nevada, United States

Las Vegas, Nevada

Las Vegas, Nevada, United States

Syracuse, New York

Syracuse, New York, United States

Asheville, North Carolina

Asheville, North Carolina, United States

Cincinnati, Ohio

Cincinnati, Ohio, United States

Cleveland, Ohio

Cleveland, Ohio, United States

Columbus, Ohio

Columbus, Ohio, United States

Dayton, Ohio

Dayton, Ohio, United States

Toledo, Ohio

Toledo, Ohio, United States

Memphis, Tennessee

Memphis, Tennessee, United States

Cypress, Texas

Cypress, Texas, United States

Georgetown, Texas

Georgetown, Texas, United States

Houston, Texas

Houston, Texas, United States

Lubbock, Texas

Lubbock, Texas, United States

Round Rock, Texas

Round Rock, Texas, United States

Burlington, Vermont

Burlington, Vermont, United States

Richmond, Virginia

Richmond, Virginia, United States

Richmond, Virginia

Richmond, Virginia, United States

Virginia Beach, Virginia

Virginia Beach, Virginia, United States

Kirkland, Washington

Kirkland, Washington, United States

Spokane, Washington

Spokane, Washington, United States

Clayton VIC

Clayton, Clayton VIC, Australia

Erina, New South Wales

Erina, New South Wales, Australia

Kogarah, New South Wales

Kogarah, New South Wales, Australia

Woolloongabba, Queensland

Woolloongabba, Queensland, Australia

Parkville, Victoria

Parkville, Victoria, Australia

Pleven, Bulgaria

Pleven, , Bulgaria

Pleven

Pleven, , Bulgaria

Multiprofile Hospital, Sofia

Sofia, , Bulgaria

Sofia

Sofia, , Bulgaria

Sofia

Sofia, , Bulgaria

DCC Neoclinic

Sofia, , Bulgaria

Sofia

Sofia, , Bulgaria

Ottawa, Ontario

Ottawa, Ontario, Canada

Toronto, Ontario

Toronto, Ontario, Canada

Chocen

Choceň, Chocen, Czechia

Prague, Czech Republic

Prague, Czech Republic, Czechia

Prague,

Prague, , Czechia

Prague,

Prague, , Czechia

Rychnov nad Kněžnou

Rychnov nad Kněžnou, , Czechia

Creteil,

Créteil, Creteil, France

Boulevard Pinel, Bron

Bron, , France

Nantes CEDEX 1

Nantes, , France

Nîmes cedex

Nîmes, , France

Strasbourg

Strasbourg, , France

Toulouse Cedex 9

Toulouse, , France

Muenster

Münster, Muenster, Germany

Bad Homburg

Bad Homburg, , Germany

Berlin

Berlin, , Germany

Bochum

Bochum, , Germany

Brandenburg, Germany

Brandenburg, , Germany

Duesseldorf,

Düsseldorf, , Germany

Gera

Gera, , Germany

Haag in Oberbayern

Haag in Oberbayern, , Germany

Klinikum rechts der Isar der TU München

Munich, , Germany

Muenchen

München, , Germany

Stadtroda

Stadtroda, , Germany

Gyor,

Győr, Gyor, Hungary

Budapest

Budapest, , Hungary

Pecs

Pécs, , Hungary

Szeged

Szeged, , Hungary

Ashkelon

Ashkelon, , Israel

Haifa

Haifa, , Israel

Jerusalem

Jerusalem, , Israel

Petah Tiqva

Petah Tikva, , Israel

Shoham

Shoham, , Israel

Tel Aviv

Tel Aviv, , Israel

Ancona

Ancona, , Italy

Cassino

Cassino, , Italy

Milano

Milan, , Italy

Padova

Padua, , Italy

Pisa

Pisa, , Italy

Rome

Rome, , Italy

Rome

Rome, , Italy

Rome

Rome, , Italy

Rozzano Milano

Rozzano, , Italy

Torino

Torino, , Italy

Cracow

Krakow, Cracow, Poland

Krakow

Krakow, Krakow, Poland

Bydgoszcz, Kujawsko-Pomorskie

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Siemianowice Slaskie

Siemianowice Śląskie, Siemianowice Slaskie, Poland

Katowice

Katowice, , Poland

Katowice

Katowice, , Poland

Kraków

Krakow, , Poland

Krakow

Krakow, , Poland

Lublin

Lublin, , Poland

Centrum Medyczne Hope Clinic Sebastian Szklener

Lublin, , Poland

Warsaw

Warsaw, , Poland

Singua

Warsaw, , Poland

Lodz

Lodz, Łódź Voivodeship, Poland

Belgrade, Serbia

Belgrade, , Serbia

Belgrade,

Belgrade, , Serbia

Belgrade

Belgrade, , Serbia

Belgrade, Kragujevac

Belgrade, , Serbia

Elche

Elche, Alicante, Spain

Barcelona

Barcelona, , Spain

Barcelona

Barcelona, , Spain

Barcelona

Barcelona, , Spain

San Sebastian

Donostia / San Sebastian, , Spain

Madrid

Madrid, , Spain

Madrid, Spain

Madrid, , Spain

Pamplona

Pamplona, , Spain

Sevilla

Seville, , Spain

Terrassa

Terrassa, , Spain

Valencia

Valencia, , Spain

Zaporiizhzhya

Zaporizhzhya, Zaporiizhzhya, Ukraine

Zaporozhya

Zaporizhzhya, Zaporozhya, Ukraine

Zaporozhya

Zaporizhzhya, Zaporozhya, Ukraine

Dnipro

Dnipro, , Ukraine

Kharkiv

Kharkiv, , Ukraine

Kiev

Kiev, , Ukraine

Lviv

Lviv, , Ukraine

Vinnitsa

Vinnitsa, , Ukraine

Countries

United States; Australia; Bulgaria; Canada; Czechia; France; Germany; Hungary; Israel; Italy; Poland; Serbia; Spain; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.abbvieclinicaltrials.com/study/?id=CVL-751-PD-003

Related Info

Other Identifiers

2019-002951-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CVL-751-PD-003

Identifier Type: -

Identifier Source: org_study_id