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New Parkinson's drug shows promise in Year-Long trial

NCT ID NCT04760769

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and effectiveness of tavapadon, an experimental drug, in 992 people with Parkinson's disease over 58 weeks. Participants took flexible doses of the medication to see how well it controlled symptoms and what side effects occurred. The goal was to understand if tavapadon is a safe long-term treatment option for managing Parkinson's.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

992 people

The number who actually took part.

Started

Feb 2021

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Albany, New York

    Albany, New York, 12208, United States

  • Ancona

    Ancona, 60126, Italy

  • Asheville, North Carolina

    Asheville, North Carolina, 28806, United States

  • Augusta, Georgia

    Augusta, Georgia, 30912, United States

  • Bad Homburg

    Bad Homburg, 61348, Germany

  • Barcelona

    Barcelona, 08035, Spain

  • Barcelona

    Barcelona, 08041, Spain

  • Belgrade

    Belgrade, 11000, Serbia

  • Belgrade,

    Belgrade, 11000, Serbia

  • Belgrade, Kragujevac

    Belgrade, 11060, Serbia

  • Belgrade, Serbia

    Belgrade, 11000, Serbia

  • Berlin

    Berlin, 12163, Germany

  • Birmingham, Alabama

    Birmingham, Alabama, 35233, United States

  • Boca Raton, Florida

    Boca Raton, Florida, 33486, United States

  • Bochum

    Bochum, 44791, Germany

  • Boston, Massachusettes

    Boston, Massachusetts, 02215, United States

  • Boulevard Pinel, Bron

    Bron, 69500, France

  • Budapest

    Budapest, 1135, Hungary

  • Burlington, Vermont

    Burlington, Vermont, 05401, United States

  • Camden, New Jersey

    Camden, New Jersey, 08103, United States

  • Cassino

    Cassino, 03043, Italy

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, 20-701, Poland

  • Centrum Medyczne NEUROMED

    Bydgoszcz, 85-163, Poland

  • Chicago, Illinois

    Chicago, Illinois, 60612, United States

  • Chocen

    Choceň, Chocen, 56501, Czechia

  • Cincinnati, Ohio

    Cincinnati, Ohio, 45212, United States

  • Clayton, Victoria

    Clayton, Victoria, 3168, Australia

  • Cleveland, Ohio

    Cleveland, Ohio, 44195, United States

  • Columbus, Ohio

    Columbus, Ohio, 43221, United States

  • Coral Springs, Florida

    Coral Springs, Florida, 33067, United States

  • Cracow

    Krakow, Cracow, 31-505, Poland

  • Creteil,

    Créteil, Creteil, 94010, France

  • Dayton, Ohio

    Dayton, Ohio, 45459, United States

  • Dnipro

    Dnipro, 49005, Ukraine

  • Dnipro

    Dnipro, 49027, Ukraine

  • Durham, North Carolina

    Durham, North Carolina, 27705, United States

  • East Lansing, Michigan

    East Lansing, Michigan, 48824, United States

  • Elche

    Elche, Alicante, 03203, Spain

  • Englewood, Colorado

    Englewood, Colorado, 80113, United States

  • Erina, New South Wales

    Erina, New South Wales, 2250, Australia

  • Florida, United States

    Adventura, Florida, 33180, United States

  • Fountain Valley, California

    Fountain Valley, California, 92708, United States

  • Fresno, California

    Fresno, California, 93710, United States

  • Georgetown, Texas

    Georgetown, Texas, 78628, United States

  • Gera

    Gera, D-07551, Germany

  • Grenoble cedex

    Grenoble, 38043, France

  • Haag in Oberbayern

    Haag in Oberbayern, 83527, Germany

  • Haifa

    Haifa, 3109601, Israel

  • Houston, Texas

    Houston, Texas, 77030, United States

  • Kansas City

    Kansas City, Kansas, 66160, United States

  • Katowice

    Katowice, 40-097, Poland

  • Katowice

    Katowice, 40-123, Poland

  • Kirkland, Washington

    Kirkland, Washington, 98034, United States

  • Klinikum rechts der Isar der TU München

    Munich, 81675, Germany

  • Kogarah

    Kogarah, New South Wales, 2217, Australia

  • Krakow

    Krakow, 30-539, Poland

  • Krakow

    Krakow, 30-721, Poland

  • Kraków

    Krakow, 30-510, Poland

  • Las Vegas, Nevada

    Las Vegas, Nevada, 89106, United States

  • Lawrence, Massachusetts

    Lawrence, Massachusetts, 01843, United States

  • Lexington, Kentucky

    Lexington, Kentucky, 40536, United States

  • Little Rock, Arkansas

    Little Rock, Arkansas, 72205, United States

  • Los Angeles, California

    Los Angeles, California, 90048, United States

  • Lubbock, Texas

    Lubbock, Texas, 79410, United States

  • Lublin

    Lublin, 20-016, Poland

  • Lviv

    Lviv, Ukraine

  • Macquarie Park, New South Wales

    Sydney, New South Wales, 2109, Australia

  • Madrid

    Madrid, 28006, Spain

  • Maitland, Florida

    Maitland, Florida, 32751, United States

  • Medical Center, Zaporizhzhya

    Zaporizhzhya, 69035, Ukraine

  • Medical center VITA1, Pleven

    Pleven, 5800, Bulgaria

  • Memphis, Tennessee

    Memphis, Tennessee, 38157, United States

  • Milano

    Milan, 20132, Italy

  • Milano, Italy

    Milan, 20126, Italy

  • Muenchen

    München, 81377, Germany

  • Muenster

    Münster, Muenster, 48149, Germany

  • Multiprofile Hospital, Sofia

    Sofia, 1113, Bulgaria

  • Móstoles, Madrid

    Madrid, 28938, Spain

  • Nancy

    Nancy, 54035, France

  • Naples, Florida

    Naples, Florida, 34102, United States

  • Nîmes cedex 09

    Nîmes, 30029, France

  • Ocala, Florida

    Ocala, Florida, 34470, United States

  • Ottawa, Ontario

    Ottawa, Ontario, K1Y4E9, Canada

  • Padova

    Padova, 35128, Italy

  • Pamplona

    Pamplona, 31008, Spain

  • Parkville, Victoria

    Parkville, Victoria, 3050, Australia

  • Pasadena, California

    Pasadena, California, 91105, United States

  • Pecs

    Pécs, 7623, Hungary

  • Petah Tiqva

    Petah Tikva, 49100, Israel

  • Pheonix, Arizona

    Phoenix, Arizona, 85004, United States

  • Philadelphia, Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

  • Pisa

    Pisa, 56126, Italy

  • Pleven

    Pleven, 5800, Bulgaria

  • Pleven, Bulgaria

    Pleven, 5800, Bulgaria

  • Port Charlotte, Florida

    Port Charlotte, Florida, 33980, United States

  • Port Orange, Florida

    Port Orange, Florida, 32127, United States

  • Prague,

    Prague, 100 00, Czechia

  • Prague,

    Prague, 160 00, Czechia

  • Prague, Czech Republic

    Prague, Czech Republic, 150 00, Czechia

  • Ramat Gan

    Ramat Gan, 5265601, Israel

  • Reseda, California

    Reseda, California, 91335, United States

  • Richmond, Virginia

    Richmond, Virginia, 23229, United States

  • Richmond, Virginia

    Richmond, Virginia, 23233, United States

  • Rome

    Rome, 00133, Italy

  • Rome

    Rome, 00163, Italy

  • Rome

    Rome, 00179, Italy

  • Round Rock, Texas

    Round Rock, Texas, 78681, United States

  • Rychnov nad Kněžnou

    Rychnov nad Kněžnou, 516 01, Czechia

  • San Sebastian

    Donostia / San Sebastian, 20009, Spain

  • Sant Cugat del Vallés Barcelona

    Barcelona, 08190, Spain

  • Scarborough, Maine

    Scarborough, Maine, 04074, United States

  • Sevilla

    Seville, 41013, Spain

  • Shoham

    Shoham, 6083531, Israel

  • Siemianowice Slaskie

    Siemianowice Śląskie, Siemianowice Slaskie, 41-100, Poland

  • Singua

    Warsaw, 02-777, Poland

  • Sofia

    Sofia, 1142, Bulgaria

  • Sofia

    Sofia, 1407, Bulgaria

  • Sofia

    Sofia, 1431, Bulgaria

  • Spokane, Washington

    Spokane, Washington, 99202, United States

  • Stadtroda

    Stadtroda, 07646, Germany

  • Strasbourg

    Strasbourg, 67098, France

  • Syracuse, New York

    Syracuse, New York, 13210, United States

  • Tampa, Florida

    Tampa, Florida, 33615, United States

  • Tatabanya

    Tatabánya, 2800, Hungary

  • Tel Aviv

    Tel Aviv, 6100000, Israel

  • Terrassa

    Terrassa, 08222, Spain

  • Toledo, Ohio

    Toledo, Ohio, 43614, United States

  • Torino

    Torino, 10126, Italy

  • Toronto, Ontario

    Toronto, Ontario, M5T 2S8, Canada

  • Toulouse Cedex 9

    Toulouse, 31059, France

  • Valencia

    Valencia, 46026, Spain

  • Vinnitsa

    Vinnitsa, 21050, Ukraine

  • Virginia Beach, Virginia

    Virginia Beach, Virginia, 23456, United States

  • Warsaw

    Warsaw, 01-868, Poland

  • West Bloomfield

    West Bloomfield, Michigan, 48322, United States

  • Winfield, Illinois

    Winfield, Illinois, 60190, United States

  • Winter Park, Florida

    Winter Park, Florida, 32792, United States

  • Woolloongabba, Queensland

    Woolloongabba, Queensland, 4102, Australia

  • Zaporiizhzhya

    Zaporizhzhya, Zaporiizhzhya, 69600, Ukraine

  • Zaporozhya

    Zaporizhzhya, Zaporozhya, 69000, Ukraine

More trials for these conditions

Other studies related to the condition(s) this trial covers.