Clinical trial NCT04760769: Open-label Trial in Parkinson's Disease (PD)
Official title: 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: Parkinsonian Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-02-18
Enrollment: 992
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

Rollover participants are eligible for the study if they met the following inclusion criteria:

* 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.

Key Exclusion criteria:

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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 62 Weeks
measure: Number of Participants Who Discontinued Study Treatment
timeFrame: 62 Weeks
measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS)
timeFrame: 58 Weeks
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 58 Weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 60 Weeks
measure: Study Medication Withdrawal Questionnaire (SMWQ)
timeFrame: 60 Weeks
measure: Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III
timeFrame: 60 Weeks
measure: Change From Baseline in the Hauser diary
timeFrame: 58 Weeks
measure: Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index
timeFrame: Baseline (Day 1), Weeks 32 and 58
measure: Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS)
timeFrame: Baseline (Day 1), Weeks 32 and 58
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham, Alabama
state: Alabama
city: Phoenix
country: United States
facility: Pheonix, Arizona
state: Arizona
city: Little Rock
country: United States
facility: Little Rock, Arkansas
state: Arkansas
city: Fountain Valley
country: United States
facility: Fountain Valley, California
state: California
city: Fresno
country: United States
facility: Fresno, California
state: California
city: Los Angeles
country: United States
facility: Los Angeles, California
state: California
city: Pasadena
country: United States
facility: Pasadena, California
state: California
city: Reseda
country: United States
facility: Reseda, California
state: California
city: Englewood
country: United States
facility: Englewood, Colorado
state: Colorado
city: Adventura
country: United States
facility: Florida, United States
state: Florida
city: Boca Raton
country: United States
facility: Boca Raton, Florida
state: Florida
city: Coral Springs
country: United States
facility: Coral Springs, Florida
state: Florida
city: Maitland
country: United States
facility: Maitland, Florida
state: Florida
city: Naples
country: United States
facility: Naples, Florida
state: Florida
city: Ocala
country: United States
facility: Ocala, Florida
state: Florida
city: Port Charlotte
country: United States
facility: Port Charlotte, Florida
state: Florida
city: Port Orange
country: United States
facility: Port Orange, Florida
state: Florida
city: Tampa
country: United States
facility: Tampa, Florida
state: Florida
city: Winter Park
country: United States
facility: Winter Park, Florida
state: Florida
city: Augusta
country: United States
facility: Augusta, Georgia
state: Georgia
city: Chicago
country: United States
facility: Chicago, Illinois
state: Illinois
city: Winfield
country: United States
facility: Winfield, Illinois
state: Illinois
city: Kansas City
country: United States
facility: Kansas City
state: Kansas
city: Lexington
country: United States
facility: Lexington, Kentucky
state: Kentucky
city: Scarborough
country: United States
facility: Scarborough, Maine
state: Maine
city: Boston
country: United States
facility: Boston, Massachusettes
state: Massachusetts
city: Lawrence
country: United States
facility: Lawrence, Massachusetts
state: Massachusetts
city: East Lansing
country: United States
facility: East Lansing, Michigan
state: Michigan
city: West Bloomfield
country: United States
facility: West Bloomfield
state: Michigan
city: Las Vegas
country: United States
facility: Las Vegas, Nevada
state: Nevada
city: Camden
country: United States
facility: Camden, New Jersey
state: New Jersey
city: Albany
country: United States
facility: Albany, New York
state: New York
city: Syracuse
country: United States
facility: Syracuse, New York
state: New York
city: Asheville
country: United States
facility: Asheville, North Carolina
state: North Carolina
city: Durham
country: United States
facility: Durham, North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati, Ohio
state: Ohio
city: Cleveland
country: United States
facility: Cleveland, Ohio
state: Ohio
city: Columbus
country: United States
facility: Columbus, Ohio
state: Ohio
city: Dayton
country: United States
facility: Dayton, Ohio
state: Ohio
city: Toledo
country: United States
facility: Toledo, Ohio
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia, Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Memphis, Tennessee
state: Tennessee
city: Georgetown
country: United States
facility: Georgetown, Texas
state: Texas
city: Houston
country: United States
facility: Houston, Texas
state: Texas
city: Lubbock
country: United States
facility: Lubbock, Texas
state: Texas
city: Round Rock
country: United States
facility: Round Rock, Texas
state: Texas
city: Burlington
country: United States
facility: Burlington, Vermont
state: Vermont
city: Richmond
country: United States
facility: Richmond, Virginia
state: Virginia
city: Richmond
country: United States
facility: Richmond, Virginia
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Beach, Virginia
state: Virginia
city: Kirkland
country: United States
facility: Kirkland, Washington
state: Washington
city: Spokane
country: United States
facility: Spokane, Washington
state: Washington
city: Erina
country: Australia
facility: Erina, New South Wales
state: New South Wales
city: Kogarah
country: Australia
facility: Kogarah
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie Park, New South Wales
state: New South Wales
city: Woolloongabba
country: Australia
facility: Woolloongabba, Queensland
state: Queensland
city: Clayton
country: Australia
facility: Clayton, Victoria
state: Victoria
city: Parkville
country: Australia
facility: Parkville, Victoria
state: Victoria
city: Pleven
country: Bulgaria
facility: Medical center VITA1, Pleven
city: Pleven
country: Bulgaria
facility: Pleven, Bulgaria
city: Pleven
country: Bulgaria
facility: Pleven
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital, Sofia
city: Sofia
country: Bulgaria
facility: Sofia
city: Sofia
country: Bulgaria
facility: Sofia
city: Sofia
country: Bulgaria
facility: Sofia
city: Ottawa
country: Canada
facility: Ottawa, Ontario
state: Ontario
city: Toronto
country: Canada
facility: Toronto, Ontario
state: Ontario
city: Choceň
country: Czechia
facility: Chocen
state: Chocen
city: Prague
country: Czechia
facility: Prague, Czech Republic
state: Czech Republic
city: Prague
country: Czechia
facility: Prague,
city: Prague
country: Czechia
facility: Prague,
city: Rychnov Nad Kněžnou
country: Czechia
facility: Rychnov nad Kněžnou
city: Créteil
country: France
facility: Creteil,
state: Creteil
city: Bron
country: France
facility: Boulevard Pinel, Bron
city: Grenoble
country: France
facility: Grenoble cedex
city: Nancy
country: France
facility: Nancy
city: Nîmes cedex 09
country: France
facility: Nîmes cedex 09
city: Strasbourg
country: France
facility: Strasbourg
city: Toulouse
country: France
facility: Toulouse Cedex 9
city: Münster
country: Germany
facility: Muenster
state: Muenster
city: Bad Homburg
country: Germany
facility: Bad Homburg
city: Berlin
country: Germany
facility: Berlin
city: Bochum
country: Germany
facility: Bochum
city: Gera
country: Germany
facility: Gera
city: Haag In Oberbayern
country: Germany
facility: Haag in Oberbayern
city: Muenchen
country: Germany
facility: Muenchen
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TU München
city: Stadtroda
country: Germany
facility: Stadtroda
city: Budapest
country: Hungary
facility: Budapest
city: Pécs
country: Hungary
facility: Pecs
city: Tatabánya
country: Hungary
facility: Tatabanya
city: Haifa
country: Israel
facility: Haifa
city: Petah Tiqva
country: Israel
facility: Petah Tiqva
city: Ramat Gan
country: Israel
facility: Ramat Gan
city: Shoham
country: Israel
facility: Shoham
city: Tel Aviv
country: Israel
facility: Tel Aviv
city: Ancona
country: Italy
facility: Ancona
city: Cassino
country: Italy
facility: Cassino
city: Milano
country: Italy
facility: Milano, Italy
city: Milano
country: Italy
facility: Milano
city: Padova
country: Italy
facility: Padova
city: Pisa
country: Italy
facility: Pisa
city: Rome
country: Italy
facility: Rome
city: Rome
country: Italy
facility: Rome
city: Rome
country: Italy
facility: Rome
city: Torino
country: Italy
facility: Torino
city: Cracovia
country: Poland
facility: Cracow
state: Cracow
city: Siemianowice Śląskie
country: Poland
facility: Siemianowice Slaskie
state: Siemianowice Slaskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne NEUROMED
city: Katowice
country: Poland
facility: Katowice
city: Katowice
country: Poland
facility: Katowice
city: Krakow
country: Poland
facility: Krakow
city: Krakow
country: Poland
facility: Krakow
city: Kraków
country: Poland
facility: Kraków
city: Lublin
country: Poland
facility: Lublin
city: Lublin
country: Poland
facility: Centrum Medyczne Hope Clinic Sebastian Szklener
city: Warsaw
country: Poland
facility: Warsaw
city: Warsaw
country: Poland
facility: Singua
city: Belgrade
country: Serbia
facility: Belgrade, Serbia
city: Belgrade
country: Serbia
facility: Belgrade,
city: Belgrade
country: Serbia
facility: Belgrade
city: Belgrade
country: Serbia
facility: Belgrade, Kragujevac
city: Elche
country: Spain
facility: Elche
state: Alicante
city: Barcelona
country: Spain
facility: Barcelona
city: Barcelona
country: Spain
facility: Barcelona
city: Barcelona
country: Spain
facility: Sant Cugat del Vallés Barcelona
city: Madrid
country: Spain
facility: Madrid
city: Madrid
country: Spain
facility: Móstoles, Madrid
city: Pamplona
country: Spain
facility: Pamplona
city: San Sebastian
country: Spain
facility: San Sebastian
city: Sevilla
country: Spain
facility: Sevilla
city: Terrassa
country: Spain
facility: Terrassa
city: Valencia
country: Spain
facility: Valencia
city: Zaporizhzhya
country: Ukraine
facility: Zaporiizhzhya
state: Zaporiizhzhya
city: Zaporozhye
country: Ukraine
facility: Zaporozhya
state: Zaporozhya
city: Dnipro
country: Ukraine
facility: Dnipro
city: Dnipro
country: Ukraine
facility: Dnipro
city: Lviv
country: Ukraine
facility: Lviv
city: Vinnitsa
country: Ukraine
facility: Vinnitsa
city: Zaporizhzhya
country: Ukraine
facility: Medical Center, Zaporizhzhya
Study officials:
affiliation: AbbVie
name: ABBVIE Inc.
role: STUDY_DIRECTOR
References: