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

NCT04542499 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CVL-751-PD-0032019-002951-40
• Study Type: interventional
• Target: 507
• Locations: 14 countries
• Sites: 146

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)

  The Hauser diary 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. The total "on" time without troublesome dyskinesia will be assessed and reported at endpoint.

  Week 26

Secondary Outcomes (4)

• Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)

  Week 26

• Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)

  Week 2, 5, 8, 11, 14, 18, 22, and 26

• Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)

  Week 2, 5, 8, 11, 14, 18, 22, and 26

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

  Week 26

Study Arms (2)

Tavapadon

EXPERIMENTAL

Participants will receive a tavapadon tablet titrated 5 to 15milligrams (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 to 15 mg tablet QD 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 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).

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 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 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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (146)

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

Long beach, California

Long Beach, California, 90806, 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

Denver, Colorado

Denver, Colorado, 80210, United States

Location

Englewood, Colorado

Englewood, Colorado, 80113, United States

Location

Adventura, Florida

Adventura, Florida, 33180, United States

Location

Atlantis, Florida

Atlantis, Florida, 33462, United States

Location

Boca Raton, Florida

Boca Raton, Florida, 33486, United States

Location

Boca Raton, Florida

Boca Raton, Florida, 33487, United States

Location

Coral Springs, Florida

Coral Springs, Florida, 33067, United States

Location

Hallandale Beach, Florida

Hallandale, Florida, 33009, United States

Location

Maitland, Florida

Maitland, Florida, 32751, 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

Elk Grove Village, Illinois

Elk Grove Village, Illinois, 60007, United States

Location

Kansas City, Kansas

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

Boston Neuro Research Center

North Dartmouth, Massachusetts, 02747, United States

Location

Farmington Hills, Michigan

Farmington Hills, Michigan, 48334, United States

Location

West Bloomfield, Michigan

West Bloomfield, Michigan, 48322, United States

Location

Saint Louis, Missouri

St Louis, Missouri, 63110, United States

Location

Las Vegas, Nevada

Las Vegas, Nevada, 89106, United States

Location

Las Vegas, Nevada

Las Vegas, Nevada, 89118, United States

Location

Syracuse, New York

Syracuse, New York, 13210, United States

Location

Asheville, North Carolina

Asheville, North Carolina, 28806, 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

Memphis, Tennessee

Memphis, Tennessee, 38157, United States

Location

Cypress, Texas

Cypress, Texas, 77429, 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

Clayton VIC

Clayton, Clayton VIC, 3168, Australia

Location

Erina, New South Wales

Erina, New South Wales, 2250, Australia

Location

Kogarah, New South Wales

Kogarah, New South Wales, 2217, Australia

Location

Woolloongabba, Queensland

Woolloongabba, Queensland, 4102, Australia

Location

Parkville, Victoria

Parkville, Victoria, 3050, Australia

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

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

Nantes CEDEX 1

Nantes, 44093, France

Location

Nîmes cedex

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

Brandenburg, Germany

Brandenburg, 14547, Germany

Location

Duesseldorf,

Düsseldorf, 40225, Germany

Location

Gera

Gera, 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

Gyor,

Győr, Gyor, 9024, Hungary

Location

Budapest

Budapest, 1135, Hungary

Location

Pecs

Pécs, 7623, Hungary

Location

Szeged

Szeged, 6725, Hungary

Location

Ashkelon

Ashkelon, 7830406, Israel

Location

Haifa

Haifa, 3109601, Israel

Location

Jerusalem

Jerusalem, 91120, Israel

Location

Petah Tiqva

Petah Tikva, 49100, 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

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

Rozzano Milano

Rozzano, 20089, Italy

Location

Torino

Torino, 10126, Italy

Location

Cracow

Krakow, Cracow, 31-505, Poland

Location

Krakow

Krakow, Krakow, 30-539, Poland

Location

Bydgoszcz, Kujawsko-Pomorskie

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland

Location

Siemianowice Slaskie

Siemianowice Śląskie, Siemianowice Slaskie, 41-100, Poland

Location

Katowice

Katowice, 40-097, Poland

Location

Katowice

Katowice, 40-123, Poland

Location

Kraków

Krakow, 30-510, 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

Lodz

Lodz, Łódź Voivodeship, 90-640, 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

Barcelona

Barcelona, 08190, Spain

Location

San Sebastian

Donostia / San Sebastian, 20009, Spain

Location

Madrid

Madrid, 28006, Spain

Location

Madrid, Spain

Madrid, 28036, 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

Zaporozhya

Zaporizhzhya, Zaporozhya, 69035, Ukraine

Location

Dnipro

Dnipro, 49027, Ukraine

Location

Kharkiv

Kharkiv, 61058, Ukraine

Location

Kiev

Kiev, 04114, Ukraine

Location

Lviv

Lviv, 79010, Ukraine

Location

Vinnitsa

Vinnitsa, 21050, Ukraine

Location

Related Links

• Related Info

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
• Restrictive Agreement: No

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: September 2, 2020
• First Posted: September 9, 2020
• Study Start: September 23, 2020
• Primary Completion: January 29, 2024
• Study Completion: February 15, 2024
• Last Updated: April 4, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-04

Locations

IL (6); CZ (5); US (54); AU (5); PL (13); SE (4); FR (6); HU (4); DE (11); IT (10); UA (8); BU (7); ES (11); CA (2)