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Parkinson DiseasePhase 3NCT04542499

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

A Phase 3 study testing Tavapadon in people with Parkinson Disease, run by AbbVie at 146 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Tavapadon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
507 participants
Where
146 sitesin 14 countries
Study dates
23 Sep 2020to 15 Feb 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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).

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

146 sites in 14 countries.

146 sites in 14 countries

United States54 sites

  • Adventura, Florida

    Adventura, Florida, 33180

  • Asheville, North Carolina

    Asheville, North Carolina, 28806

  • Atlantis, Florida

    Atlantis, Florida, 33462

  • Augusta, Georgia

    Augusta, Georgia, 30912

  • Boca Raton, Florida

    Boca Raton, Florida, 33486

  • Boca Raton, Florida

    Boca Raton, Florida, 33487

  • Boston, Massachusettes

    Boston, Massachusetts, 02215

  • Burlington, Vermont

    Burlington, Vermont, 05401

  • Chicago, Illinois

    Chicago, Illinois, 60612

  • Cincinnati, Ohio

    Cincinnati, Ohio, 45212

  • Cleveland, Ohio

    Cleveland, Ohio, 44195

  • Columbus, Ohio

    Columbus, Ohio, 43221

  • Coral Springs, Florida

    Coral Springs, Florida, 33067

  • Cypress, Texas

    Cypress, Texas, 77429

  • Dayton, Ohio

    Dayton, Ohio, 45459

  • Denver, Colorado

    Denver, Colorado, 80210

  • Elk Grove Village, Illinois

    Elk Grove Village, Illinois, 60007

  • Englewood, Colorado

    Englewood, Colorado, 80113

  • Farmington Hills, Michigan

    Farmington Hills, Michigan, 48334

  • Fountain Valley, California

    Fountain Valley, California, 92708

  • Fresno, California

    Fresno, California, 93710

  • Georgetown, Texas

    Georgetown, Texas, 78628

  • Hallandale Beach, Florida

    Hallandale, Florida, 33009

  • Houston, Texas

    Houston, Texas, 77030

  • Kansas City, Kansas

    Kansas City, Kansas, 66160

  • Kirkland, Washington

    Kirkland, Washington, 98034

  • Las Vegas, Nevada

    Las Vegas, Nevada, 89106

  • Las Vegas, Nevada

    Las Vegas, Nevada, 89118

  • Lexington, Kentucky

    Lexington, Kentucky, 40536

  • Little Rock, Arkansas

    Little Rock, Arkansas, 72205

  • Long beach, California

    Long Beach, California, 90806

  • Los Angeles, California

    Los Angeles, California, 90048

  • Lubbock, Texas

    Lubbock, Texas, 79410

  • Maitland, Florida

    Maitland, Florida, 32751

  • Memphis, Tennessee

    Memphis, Tennessee, 38157

  • Boston Neuro Research Center

    North Dartmouth, Massachusetts, 02747

  • Ocala, Florida

    Ocala, Florida, 34470

  • Pasadena, California

    Pasadena, California, 91105

  • Pheonix, Arizona

    Phoenix, Arizona, 85004

  • Port Charlotte, Florida

    Port Charlotte, Florida, 33980

  • Port Orange, Florida

    Port Orange, Florida, 32127

  • Reseda, California

    Reseda, California, 91335

  • Richmond, Virginia

    Richmond, Virginia, 23229

  • Richmond, Virginia

    Richmond, Virginia, 23233

  • Round Rock, Texas

    Round Rock, Texas, 78681

  • Scarborough, Maine

    Scarborough, Maine, 04074

  • Spokane, Washington

    Spokane, Washington, 99202

  • Saint Louis, Missouri

    St Louis, Missouri, 63110

  • Syracuse, New York

    Syracuse, New York, 13210

  • Tampa, Florida

    Tampa, Florida, 33615

  • Toledo, Ohio

    Toledo, Ohio, 43614

  • Virginia Beach, Virginia

    Virginia Beach, Virginia, 23456

  • West Bloomfield, Michigan

    West Bloomfield, Michigan, 48322

  • Winter Park, Florida

    Winter Park, Florida, 32792

Other trials in United States

Poland13 sites

  • Bydgoszcz, Kujawsko-Pomorskie

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163

  • Katowice

    Katowice, 40-097

  • Katowice

    Katowice, 40-123

  • Cracow

    Krakow, Cracow, 31-505

  • Krakow

    Krakow, Krakow, 30-539

  • Kraków

    Krakow, 30-510

  • Krakow

    Krakow, 30-721

  • Lodz

    Lodz, Łódź Voivodeship, 90-640

  • Lublin

    Lublin, 20-016

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, 20-701

  • Siemianowice Slaskie

    Siemianowice Śląskie, Siemianowice Slaskie, 41-100

  • Warsaw

    Warsaw, 01-868

  • Singua

    Warsaw, 02-777

Other trials in Poland

Germany11 sites

  • Bad Homburg

    Bad Homburg, 61348

  • Berlin

    Berlin, 12163

  • Bochum

    Bochum, 44791

  • Brandenburg, Germany

    Brandenburg, 14547

  • Duesseldorf,

    Düsseldorf, 40225

  • Gera

    Gera, 07551

  • Haag in Oberbayern

    Haag in Oberbayern, 83527

  • Muenchen

    München, 81377

  • Klinikum rechts der Isar der TU München

    Munich, 81675

  • Muenster

    Münster, Muenster, 48149

  • Stadtroda

    Stadtroda, 07646

Other trials in Germany

Spain11 sites

  • Barcelona

    Barcelona, 08035

  • Barcelona

    Barcelona, 08041

  • Barcelona

    Barcelona, 08190

  • San Sebastian

    Donostia / San Sebastian, 20009

  • Elche

    Elche, Alicante, 03203

  • Madrid

    Madrid, 28006

  • Madrid, Spain

    Madrid, 28036

  • Pamplona

    Pamplona, 31008

  • Sevilla

    Seville, 41013

  • Terrassa

    Terrassa, 08222

  • Valencia

    Valencia, 46026

Other trials in Spain

Italy10 sites

  • Ancona

    Ancona, 60126

  • Cassino

    Cassino, 03043

  • Milano

    Milan, 20132

  • Padova

    Padova, 35128

  • Pisa

    Pisa, 56126

  • Rome

    Rome, 00133

  • Rome

    Rome, 00163

  • Rome

    Rome, 00179

  • Rozzano Milano

    Rozzano, 20089

  • Torino

    Torino, 10126

Other trials in Italy

Ukraine8 sites

  • Dnipro

    Dnipro, 49027

  • Kharkiv

    Kharkiv, 61058

  • Kiev

    Kiev, 04114

  • Lviv

    Lviv, 79010

  • Vinnitsa

    Vinnitsa, 21050

  • Zaporiizhzhya

    Zaporizhzhya, Zaporiizhzhya, 69600

  • Zaporozhya

    Zaporizhzhya, Zaporozhya, 69000

  • Zaporozhya

    Zaporizhzhya, Zaporozhya, 69035

Other trials in Ukraine

Bulgaria7 sites

  • Pleven, Bulgaria

    Pleven, 5800

  • Pleven

    Pleven, 5800

  • Multiprofile Hospital, Sofia

    Sofia, 1113

  • Sofia

    Sofia, 1142

  • Sofia

    Sofia, 1407

  • DCC Neoclinic

    Sofia, 1408

  • Sofia

    Sofia, 1431

Other trials in Bulgaria

France6 sites

  • Boulevard Pinel, Bron

    Bron, 69500

  • Creteil,

    Créteil, Creteil, 94010

  • Nantes CEDEX 1

    Nantes, 44093

  • Nîmes cedex

    Nîmes, 30029

  • Strasbourg

    Strasbourg, 67098

  • Toulouse Cedex 9

    Toulouse, 31059

Other trials in France

Israel6 sites

  • Ashkelon

    Ashkelon, 7830406

  • Haifa

    Haifa, 3109601

  • Jerusalem

    Jerusalem, 91120

  • Petah Tiqva

    Petah Tikva, 49100

  • Shoham

    Shoham, 6083531

  • Tel Aviv

    Tel Aviv, 6100000

Other trials in Israel

Australia5 sites

  • Clayton VIC

    Clayton, Clayton VIC, 3168

  • Erina, New South Wales

    Erina, New South Wales, 2250

  • Kogarah, New South Wales

    Kogarah, New South Wales, 2217

  • Parkville, Victoria

    Parkville, Victoria, 3050

  • Woolloongabba, Queensland

    Woolloongabba, Queensland, 4102

Other trials in Australia

Czechia5 sites

  • Chocen

    Choceň, Chocen, 56501

  • Prague, Czech Republic

    Prague, Czech Republic, 150 00

  • Prague,

    Prague, 100 00

  • Prague,

    Prague, 160 00

  • Rychnov nad Kněžnou

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Hungary4 sites

  • Budapest

    Budapest, 1135

  • Gyor,

    Győr, Gyor, 9024

  • Pecs

    Pécs, 7623

  • Szeged

    Szeged, 6725

Other trials in Hungary

Serbia4 sites

  • Belgrade, Serbia

    Belgrade, 11000

  • Belgrade,

    Belgrade, 11000

  • Belgrade

    Belgrade, 11000

  • Belgrade, Kragujevac

    Belgrade, 11060

Other trials in Serbia

Canada2 sites

  • Ottawa, Ontario

    Ottawa, Ontario, K1Y4E9

  • Toronto, Ontario

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)

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.

Being tested
Tavapadon, Placebo
Keywords
Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Disease, Movement Disorders, Neurodegenerative Diseases
Medical subject headings
Parkinson Disease, Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TavapadonDrug

    Also called PF-06649751, CVL-751

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

  • PlaceboDrug

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

Study groups in NCT04542499
Study groupRoleWhat they receive
TavapadonExperimentalParticipants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Receives: Drug: Tavapadon
PlaceboPlacebo comparatorParticipants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 26

Secondary outcomes (4)

  1. 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)

    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 daily "Off" time will be assessed and reported at endpoint.

    Measured: Week 26

  2. 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 different time points.

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

  3. 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)

    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 daily "Off" time will be assessed and reported at different time points.

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

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

    The MDS-UPDRS rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome.

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start23 Sep 2020
  3. Primary completion29 Jan 2024
  4. Study completion15 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542499
Sponsor's protocol ID
CVL-751-PD-003
Other IDs
2019-002951-40, 2019
Status last verified
Apr 2025
First submitted
2 Sep 2020
Last updated
4 Apr 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Fernandez HH, Isaacson SH, Hauser RA, Agarwal P, Ondo W, Park A, Kremens D, Leoni M, Duvvuri S, Combs C, Koenig E, Chang I, Pastino G, Tringali S, Golonski N, Sanchez R, Harmer L, Boiser J, Zadikoff C, Mari Z. Tavapadon as Adjunctive Treatment for Parkinson Disease: The TEMPO-3 Randomized Clinical Trial. JAMA Neurol. 2026 May 1;83(5):442-451. doi: 10.1001/jamaneurol.2026.0577.

    PubMed 41860544

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tavapadon in people with Parkinson Disease, run by AbbVie at 146 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Poland, Germany, Spain, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04542499, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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