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Parkinson DiseasePhase 3NCT06553027

To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications

A Phase 3 study testing CVN424 75 mg and CVN424 150 mg in people with Parkinson Disease, run by Cerevance at 94 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424 or 150 mg CVN424, or a matching placebo for 12 weeks. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
CVN424 75 mg and CVN424 150 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
94 sitesin 9 countries
Study dates
20 Sep 2024to Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of PD consistent with United Kingdom (UK) Brain Bank criteria and MDS Research Criteria for the Diagnosis of PD; must include bradykinesia with sequence effect and motor asymmetry if no rest tremor, and a prominent response to levodopa.
  • Body Mass Index (BMI) > 18.0 and < 35.0 Kilograms per meter square (kg/m^2), inclusive at Screening.
  • Modified Hoehn and Yahr Stage ≤ 3 in the ON state.
  • Freely ambulatory at the time of Screening (with/without assistive device).
  • Montreal Cognitive Assessment (MoCA) Score of at least 24.
  • PD medications must be stable for at least 4 weeks prior to Screening; monoamine oxidase B (MAO-B) inhibitors must be stable for at least 12 weeks prior to Screening.
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  • Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont).
  • Stable use of oral anti-sialorrhea medications for 30 days before Screening, without anticipated need for change during the study.
  • Average of ≥ 3 h total OFF time/day on Screening home diaries, with at least 2.5 hours OFF on each diary day.
  • During Screening, capable of adequately identifying ON, OFF, and dyskinetic states (>80% concordance) through properly completed ON/OFF diaries.
  • Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 12 weeks after the last dose of study drug has been taken.
  • Able and willing to give written informed consent approved by an institutional review board, and to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures.
  • Approved as an appropriate and suitable candidate by the Enrollment Authorization Committee (EAC)

Who cannot join

  • Diagnosis of secondary or atypical parkinsonism.
  • Severe or disabling dyskinesias or OFF expected to preclude successful study participation, in the opinion of the investigator.
  • Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine, subcutaneous levodopa), surgery for PD (i.e., deep brain stimulation [DBS]), or anticipation of these during the study.
  • History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia.
  • Clinically significant orthostatic hypotension (consistently symptomatic or requires medication).
  • Clinically significant hallucinations requiring antipsychotic use.
Show all 33Show fewer
  • Current use of strong CYP3A4/5 inhibitors or inducers.
  • Routine use of PD on-demand medications (i.e., inhaled levodopa, apomorphine injection). Routine use defined as three (3) or more uses per week of on-demand medication is not allowed. On demand medications should only be used for medical emergencies and should be avoided on anticipated diary days, as best as possible.
  • Use of injectable botulinum medication for sialorrhea within 90 days of screening or during the study.
  • Current use of medication with dopamine antagonist activity, or any use within 12 months of Screening.
  • Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the investigator would preclude adequate participation or completion of the study.
  • Clinically significant ECG abnormalities at Screening.
  • Prolonged Fridericia-corrected QT (QTcF) interval on ECG at Screening.
  • Clinically significant heart disease within 2 years of Screening, defined as follows:
  • Significant cardiac event within 12 weeks prior to Screening (e.g., admission for myocardial infarction, unstable angina, or decompensated heart failure), angina pectoris or episode of congestive heart failure with symptoms > grade 2 New York Heart Association classification, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia.
  • History of complex arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment.
  • Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
  • Symptomatic bradycardia, sick sinus syndrome or atrioventricular block greater than first degree in the absence of a pacemaker
  • Unexplained syncope
  • Brugada syndrome
  • Hypertrophic cardiomyopathy
  • Any clinically significant history of malignancy or ongoing malignancy of sufficient concern for interference with completion of the study or quality of study experience, in the opinion of the investigator and medical monitor.
  • Active major depressive disorder or a Beck Depression Inventory-II (BDI-II) score of > 19.
  • Has active suicidal ideation within one year prior to Screening as determined by the C-SSRS or attempted suicide within the last 5 years.
  • Has been diagnosed with or history of a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria, during the 12 months prior to Screening.
  • Tests positive at Screening for drugs of abuse. Drugs of abuse refers to illicit substances and does not include participants taking physician-prescribed medications. For participants who are legally prescribed cannabis for medical reasons, the appropriateness of the participant for this study will be made by the judgement of the Investigator in consultation with the Medical monitor.
  • Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN) or a degree of hepatic impairment using the Child-Pugh classification of B or C.
  • Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) less than or equal to 60 milliliters per minute (ml/min).
  • Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV) antibody, or Human Immunodeficiency Virus (HIV) infection at Screening.
  • Currently lactating or pregnant or planning to become pregnant during the study.
  • Previous exposure to CVN424.
  • Currently participating in or has participated in another study of an investigational medicinal product (IMP) or medical device in the last 3 months or within 5 half-lives of the IMP (whichever is longer) prior to Screening.
  • A known hypersensitivity to the IMP or to any excipients used in the formulation.

Trial locations and contacts

94 sites in 9 countries.

94 sites in 9 countries

United States53 sites
  • Inova Parkinson's and Movement Disorders Center - Alexandria

    Alexandria, Virginia, 22311

  • Parkinson's Research Centers of America - Orange county

    Aliso Viejo, California, 92656

  • University of Michigan Dept. of Neurology

    Ann Arbor, Michigan, 48109

  • University of Michigan Hospital - Michigan Clinical Research Unit (MCRU)

    Ann Arbor, Michigan, 48109

  • Atlanta Neuroscience Institute

    Atlanta, Georgia, 30327

  • The Kirklin Clinic of UAB Hospital

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham ALS Clinic

    Birmingham, Alabama, 35294

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • SFM Clinical Research, LLC

    Boca Raton, Florida, 33487

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Neurological Institute

    Charlotte, North Carolina, 28204

  • Riverhills Healthcare, Inc dba Riverhills Neuroscience

    Cincinnati, Ohio, 45212

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • The Ohio State University - Martha Morehouse Medical Plaza

    Columbus, Ohio, 43221

  • Parkinson's Research Centers of America - Long Island

    Commack, New York, 11725

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

  • Duke Neurology Morreene Road Clinic

    Durham, North Carolina, 27705

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado, 80113

  • Inova Neurology - Fairfax

    Fairfax, Virginia, 22031

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Texas Movement Disorder Specialists, PLLC

    Georgetown, Texas, 78628

  • Boro Neurology

    Hopewell, New Jersey, 08525

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • Gill Neuroscience

    Houston, Texas, 77065

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • EvergreenHealth Research Department

    Kirkland, Washington, 98034

  • University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research

    Lexington, Kentucky, 40536

  • K2 Medical Research

    Maitland, Florida, 32751

  • Veracity Neuroscience LLC

    Memphis, Tennessee, 38157

  • Medical College of Wisconsin-Department of Neurology

    Milwaukee, Wisconsin, 53226

  • Weill Cornell Medical College

    New York, New York, 10021

  • Parkinson's Research Centers of America - Orange County

    Newport Beach, California, 92663

  • Renstar Medical Research

    Ocala, Florida, 34471

  • N1 Research LLc

    Orlando, Florida, 32825

  • Parkinson's Research Centers of America - Palo Alto

    Palo Alto, California, 94301

  • Global Neurosciences Institute at Pennington

    Pennington, New Jersey, 08534

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Muhammad Ali Parkinson Center

    Phoenix, Arizona, 85013

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Parkinson's Disease Center of SWFL

    Port Charlotte, Florida, 33980

  • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute

    Port Orange, Florida, 32127

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607

  • Henrico Doctors Neurology Associates, LLC

    Richmond, Virginia, 23229

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Inland Northwest Research

    Spokane, Washington, 99202

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33613

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

  • David and Rhoda Chase Family Movement Disorders Center - Vernon

    Vernon, Connecticut, 06066

Other trials in United States

Spain8 sites
  • Hospital Universitario Cruces

    Barakaldo, Biscay, 48903

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Policlínica Gipuzkoa

    San Sebastián, Gipuzkoa, 20014

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08190

  • Hospital Universitario Virgen del Rocío

    Seville, Andalusia, 41013

  • Hospital Universitari i Politècnic La Fe

    Valencia, Valenciana, Comunidad, 46026

Other trials in Spain

Australia7 sites
  • Monash Health

    Cheltenham, Victoria, VIC 3192

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, NSW 2010

  • Southern Neurology

    Kogarah, New South Wales, NSW 2217

  • The Alfred

    Melbourne, Victoria, VIC 3004

  • Perron Institute for Neurological and Translational Science

    Nedlands, Western Australia, WA 6009

  • Westmead Hospital-Department of Neurology

    Sydney, New South Wales, NSW 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102

Other trials in Australia

Czechia7 sites
  • Fakultní Nemocnice u sv. Anny v Brně

    Brno, South Moravian, 656 91

  • Neurologie Taláb Radomír Doc. MUDr., CSc

    Hradec Králové, 500 03

  • Nemocnice Pardubického kraje, a.s. - Pardubická nemocnice

    Pardubičky, Pardubice, 530 03

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, Prague, 128 08

  • Praglandia s.r.o.

    Prague, Prague, 150 00

  • Axon Clinical s.r.o.

    Prague, Prague, 150 06

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 120 00

Other trials in Czechia

France5 sites
  • Hôpital Pierre Wertheimer

    Bron, Auvergne-Rhône-Alpes, 69500

  • Hôpitaux Universitaires Henri Mondor

    Créteil, Val-De-Marne, 94010

  • Hôpital Roger Salengro

    Lille, Nord, 59037

  • Hôpital Gui de Chauliac

    Montpellier, Hérault, 34295

  • Hôpital Pierre-Paul Riquet

    Toulouse, Haute-Garonne, 31059

Other trials in France

Poland5 sites
  • Neuro-Care Centrum Medyczne

    Katowice, Silesian Voivodeship, 40-001

  • Neurologia Śląska Centrum Medyczne

    Katowice, Silesian Voivodeship, 40-123

  • Wielospecjalistyczna Poradnia Lekarska Synapsis

    Katowice, Silesian Voivodeship, 40-123

  • Centrum Zdrowia i Urody MAXXMED

    Lublin, Lublin Voivodeship, 20-080

  • ETG Neuroscience Sp. z o. o

    Warsaw, Masovian Voivodeship, 02-677

Other trials in Poland

United Kingdom4 sites
  • Northern Care Alliance NHS Foundation Trust

    Bury, BL9 7TD

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

  • Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, England, NE4 5PL

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8BU

Other trials in United Kingdom

Italy3 sites
  • San Raffaele Cassino

    Cassino, Frosinone, 03043

  • Azienda Ospedale Università di Padova

    Padova, Padua, 35128

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

    Rome, 00163

Other trials in Italy

Puerto Rico2 sites
  • The Alliance Hispanic Alliance for Clinical and Translational Research

    Rio Piedras, 00935

  • Universidad de Puerto Rico Recinto de Ciencias Médicas

    San Juan, 00936-5067

Other trials in Puerto Rico

About this study

Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Complications

This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424 or 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

Being tested
CVN424 75 mg, CVN424 150 mg, Placebo
Keywords
Parkinson Disease, CVN424, Phase 3, Motor fluctuations, Idiopathic Parkinson Disease
Medical subject headings
Parkinson Disease

What participants receive

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

  • CVN424 75 mgDrug

    Participants will receive 75 mg CVN424 tablet once daily.

  • CVN424 150 mgDrug

    Participants will receive 150 mg CVN424 tablet once daily.

  • PlaceboDrug

    Participants will receive matching placebo tablet once daily.

Study groups in NCT06553027
Study groupRoleWhat they receive
CVN424 75 mgExperimentalParticipants will be administered with oral doses of 75 mg CVN424.
Receives: Drug: CVN424 75 mg
CVN424 150 mgExperimentalParticipants will be administered with oral doses of 150 mg CVN424.
Receives: Drug: CVN424 150 mg
PlaceboPlacebo comparatorParticipants will be administered with placebo.
Receives: Drug: Placebo

What is being measured

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

  1. Change from Baseline to Week 12 in average daily OFF time on motor diaries for 150 mg CVN424 compared to placebo

    The assessment of the average daily OFF time, normalized to waking hours will be based on diaries completed at home for three consecutive days during the 7-day period before a scheduled in-person visit.

    Measured: Baseline and Up to Week 12

Secondary outcomes (18)
  1. Change from Baseline to Week 12 in the ON time without troublesome dyskinesia

    The assessment of the ON time without troublesome dyskinesia will be based on diaries completed at home for three consecutive days during the 7-day period before a scheduled in-person visit.

    Measured: Baseline and Up to Week 12

  2. Change from Baseline to Week 12 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

    The MDS-UPDRS is a comprehensive 50-question assessment of both motor and non-motor symptoms associated with PD. It features sections that require independent completion by people with PD and their caregivers, and sections to be completed by the same clinician throughout the study. Part II assess motor experiences of daily living, motor aspects of experiences of daily living. This part has 13 items. It is a self-administered questionnaire completed by the participant, which can be reviewed by the Investigator to ensure all responses are completed.

    Measured: Baseline and Up to Week 12

  3. Change from Baseline to Week 12 on the Clinical Global Impression Scale - Severity (CGI-S)

    The CGI-S is a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal/not at all ill) to 7 (amongst the most severely ill participants). This requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Higher scores indicate worser the illness.

    Measured: Baseline and Up to Week 12

  4. Change from Baseline to Week 12 on the Patient Global Impression Scale - Severity (PGI-S)

    The PGI-S is a participant-completed assessment rating PD severity on a scale of 1 to 5 with 1 being none and 5 being very severe. Higher scores indicate worser the illness.

    Measured: Baseline and Up to Week 12

  5. Change from Baseline to Week 12 on the MDS-UPDRS Part III

    The MDS-UPDRS is a comprehensive 50-question assessment of both motor and non-motor symptoms associated with PD. It features sections that require independent completion by people with PD and their caregivers, and sections to be completed by the same clinician throughout the study. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0 (normal) to 4(severe). A 0 means there is no disability, and the higher the score, the more the disability is reflected. The maximum score for Part III is 132. The total score is the sum of the numerical response values of the items. It is completed by a rater based on findings from the motor examination.

    Measured: Baseline and Up to Week 12

  6. Change from Baseline to Week 12 on the Epworth Sleepiness Scale (ESS)

    The ESS is a participant self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0 to 3: would never doze, slight chance of dozing, moderate chance of dozing, and high chance of dozing), their usual chances of dozing off or falling asleep while engaged in eight different activities, such as sitting and reading, watching television, sitting in a public place, etc. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their "daytime sleepiness". The questionnaire takes no more than 2 or 3 minutes to answer.

    Measured: Baseline and Up to Week 12

  7. Change from Baseline to Week 12 in the ON time with no dyskinesia

    The assessment of the ON time with no dyskinesia will be based on diaries completed at home for three consecutive days during the 7-day period before a scheduled in-person visit.

    Measured: Baseline and Up to Week 12

  8. Change from Baseline to Week 12 on the MDS-UPDRS Part I

    The MDS-UPDRS is a comprehensive 50-question assessment of both motor and non-motor symptoms associated with PD. It features sections that require independent completion by people with PD and their caregivers, and sections to be completed by the same clinician throughout the study. Part I assess non-motor experiences of daily living, non-motor aspects of experiences of daily living (6 items assessed by interview and 7 items by self-assessment). It has 13 items and is further grouped into two parts: Part IA has items associated with behaviors that are assessed and completed by the rater based on information provided by the participant and caregiver. Part IB is self-administered and completed by the participant with or without assistance or input from the caregiver, but independently of the rater. Responses to both IA and IB can be reviewed by the rater to ensure information accuracy and/or provide additional information or clarification of the test items, if necessary.

    Measured: Baseline and Up to Week 12

  9. Change from Baseline to Week 12 on the Parkinson's Disease Questionnaire-39 (PDQ-39)

    The PDQ is a 39-item self-report questionnaire that assesses eight PD-specific health related quality of life functions over the previous month. Assesses how often participants with PD experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. The 39-item questionnaire offers a participant reported measure of health status and quality of life and is the most frequently used disease-specific health status measure. It also assesses the impact of PD on specific dimensions of functioning and wellbeing.

    Measured: Baseline and Up to Week 12

  10. Change from Baseline to Week 12 on the Starkstein Apathy Scale (SAS)

    The SAS instrument is used to identify apathy in participants with PD. The scale comprises 14 questions in which the respondent self-rates on a 4-point scale, ranging from "Not at all", "Slightly", "Some", and "A Lot". Ratings are a score from 3 to 0 for questions 1-8, and from 0 to 3 for questions 9-14, producing a total score out of 42. A score above 14 is considered the more severe level of apathy.

    Measured: Baseline and Up to Week 12

  11. Change from Baseline to Week 12 on the CogState digital cognitive battery

    Cogstate Digital Cognitive Testing Battery are computerized cognitive assessments of attention, executive function, verbal learning, and memory. It uses standardized scores to assess participant's cognitive function. These scores are transformed into a scale where the average performance of the general population is set at 100, with a standard deviation of 15. This means that a score of 100 represents average cognitive function, while scores above or below indicate better or poorer performance, respectively, compared to the average.

    Measured: Baseline and Up to Week 12

  12. Change from Baseline to Week 12 on the Schwab and England (S & E) Activities of Daily Living Scale (ADL)

    The Schwab and England Activities of Daily Living Scale is a commonly used tool to measure daily function for Parkinson's disease. The S \& E Scale rates a PD participant's function on a scale from 0 indicating worst possible function to 100 indicating no impairment.

    Measured: Baseline and Up to Week 12

  13. Number of participants reporting treatment emergent adverse events (TEAEs), TEAEs related to moderate or severe intensity and leading to withdrawal of study drug

    Measured: Up to Week 14

  14. Number of participants reporting serious adverse events (SAEs)

    Measured: Up to Week 14

  15. Number of participants with suicidal ideation as measured by Columbia Suicide Severity Rating Scale (C-SSRS)

    Measured: Up to Week 12

  16. Number of participants with impulse control disorders as measured by the Questionnaire for Impulsive-Compulsive Disorders in Parkinson 's disease Rating Scale (QUIP-RS)

    The QUIP-RS has 4 questions (common thoughts, urges/desires, self-control, faciliatory behaviors associated with impulse control disorders [ICDs]), each applied to 4 main impulse control disorders (gambling, buying, eating, and sexual behavior) and 3 related impulsivity disorders (medication use, punding, and hobbyism). Scores range from 0-4 for each question to gauge the frequency of behaviors over the preceding 4 weeks (or any defined 4-week period). Total scores range from 0 to 112.

    Measured: Up to Week 12

  17. Number of participants with clinically significant changes in physical examination, vital signs, electrocardiogram (ECG) finding, and laboratory values

    Measured: Up to Week 14

  18. Percentage of completers

    Measured: Up to Week 12

Timeline

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

  1. First posted14 Aug 2024
  2. Study start20 Sep 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06553027
Sponsor's protocol ID
CVN424-301
Other IDs
2024-516811-25-00
Status last verified
Apr 2026
First submitted
9 Aug 2024
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CVN424 75 mg and CVN424 150 mg in people with Parkinson Disease, run by Cerevance at 94 sites in 9 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 13 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Spain, Australia, Czechia, France and 4 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?

This study is still under way. Results are not available in the source record yet.

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 to Week 12 in average daily OFF time on motor diaries for 150 mg CVN424 compared to placebo (time frame: Baseline and Up to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Apr 2026.

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