Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
992 participants
INTERVENTIONAL
2021-02-24
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tavapadon
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.
Tavapadon
Participants will receive Tavapadon at a dose of (5 to 15) mg QD, orally during a 58-week treatment period.
Interventions
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Tavapadon
Participants will receive Tavapadon at a dose of (5 to 15) mg QD, orally during a 58-week treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Birmingham, Alabama
Birmingham, Alabama, United States
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
Los Angeles, California
Los Angeles, California, United States
Pasadena, California
Pasadena, California, United States
Reseda, California
Reseda, California, United States
Englewood, Colorado
Englewood, Colorado, United States
Florida, United States
Adventura, Florida, United States
Boca Raton, Florida
Boca Raton, Florida, United States
Coral Springs, Florida
Coral Springs, Florida, United States
Maitland, Florida
Maitland, Florida, United States
Naples, Florida
Naples, 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
Winfield, Illinois
Winfield, Illinois, United States
Kansas City
Kansas City, Kansas, United States
Lexington, Kentucky
Lexington, Kentucky, United States
Scarborough, Maine
Scarborough, Maine, United States
Boston, Massachusettes
Boston, Massachusetts, United States
Lawrence, Massachusetts
Lawrence, Massachusetts, United States
East Lansing, Michigan
East Lansing, Michigan, United States
West Bloomfield
West Bloomfield, Michigan, United States
Las Vegas, Nevada
Las Vegas, Nevada, United States
Camden, New Jersey
Camden, New Jersey, United States
Albany, New York
Albany, New York, United States
Syracuse, New York
Syracuse, New York, United States
Asheville, North Carolina
Asheville, North Carolina, United States
Durham, North Carolina
Durham, 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
Philadelphia, Pennsylvania
Philadelphia, Pennsylvania, United States
Memphis, Tennessee
Memphis, Tennessee, 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
Erina, New South Wales
Erina, New South Wales, Australia
Kogarah
Kogarah, New South Wales, Australia
Macquarie Park, New South Wales
Sydney, New South Wales, Australia
Woolloongabba, Queensland
Woolloongabba, Queensland, Australia
Clayton, Victoria
Clayton, Victoria, Australia
Parkville, Victoria
Parkville, Victoria, Australia
Medical center VITA1, Pleven
Pleven, , Bulgaria
Pleven, Bulgaria
Pleven, , Bulgaria
Pleven
Pleven, , Bulgaria
Multiprofile Hospital, Sofia
Sofia, , Bulgaria
Sofia
Sofia, , Bulgaria
Sofia
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
Grenoble cedex
Grenoble, , France
Nancy
Nancy, , France
Nîmes cedex 09
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
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
Budapest
Budapest, , Hungary
Pecs
Pécs, , Hungary
Tatabanya
Tatabánya, , Hungary
Haifa
Haifa, , Israel
Petah Tiqva
Petah Tikva, , Israel
Ramat Gan
Ramat Gan, , Israel
Shoham
Shoham, , Israel
Tel Aviv
Tel Aviv, , Israel
Ancona
Ancona, , Italy
Cassino
Cassino, , Italy
Milano, Italy
Milan, , Italy
Milano
Milan, , Italy
Padova
Padua, , Italy
Pisa
Pisa, , Italy
Rome
Rome, , Italy
Rome
Rome, , Italy
Rome
Rome, , Italy
Torino
Torino, , Italy
Cracow
Krakow, Cracow, Poland
Siemianowice Slaskie
Siemianowice Śląskie, Siemianowice Slaskie, Poland
Centrum Medyczne NEUROMED
Bydgoszcz, , Poland
Katowice
Katowice, , Poland
Katowice
Katowice, , Poland
Kraków
Krakow, , Poland
Krakow
Krakow, , Poland
Krakow
Krakow, , Poland
Lublin
Lublin, , Poland
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, , Poland
Warsaw
Warsaw, , Poland
Singua
Warsaw, , 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
Sant Cugat del Vallés Barcelona
Barcelona, , Spain
San Sebastian
Donostia / San Sebastian, , Spain
Madrid
Madrid, , Spain
Móstoles, Madrid
Madrid, , Spain
Pamplona
Pamplona, , Spain
Sevilla
Seville, , Spain
Terrassa
Terrassa, , Spain
Valencia
Valencia, , Spain
Zaporiizhzhya
Zaporizhzhya, Zaporiizhzhya, Ukraine
Zaporozhya
Zaporizhzhya, Zaporozhya, Ukraine
Dnipro
Dnipro, , Ukraine
Dnipro
Dnipro, , Ukraine
Lviv
Lviv, , Ukraine
Vinnitsa
Vinnitsa, , Ukraine
Medical Center, Zaporizhzhya
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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2019-002952-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CVL-751-PD-004
Identifier Type: -
Identifier Source: org_study_id