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.
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.
Show all 13Show fewer
- 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
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
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
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
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
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
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
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
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
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.
- Conditions
- Parkinson Disease
- 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 group | Role | What they receive |
|---|---|---|
| CVN424 75 mg | Experimental | Participants will be administered with oral doses of 75 mg CVN424. Receives: Drug: CVN424 75 mg |
| CVN424 150 mg | Experimental | Participants will be administered with oral doses of 150 mg CVN424. Receives: Drug: CVN424 150 mg |
| Placebo | Placebo comparator | Participants 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of participants reporting serious adverse events (SAEs)
Measured: Up to Week 14
Number of participants with suicidal ideation as measured by Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Week 12
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
Number of participants with clinically significant changes in physical examination, vital signs, electrocardiogram (ECG) finding, and laboratory values
Measured: Up to Week 14
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.
- First posted14 Aug 2024
- Study start20 Sep 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cerevance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Complications
- ClinicalTrials.gov ID
- NCT06553027
- Acronym / sponsor ID
- CVN424-301
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, CVN424, Phase 3, Motor fluctuations, Idiopathic Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- CerevanceIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CVN424 75 mg | Experimental | Drug: CVN424 75 mgParticipants will be administered with oral doses of 75 mg CVN424. |
| CVN424 150 mg | Experimental | Drug: CVN424 150 mgParticipants will be administered with oral doses of 150 mg CVN424. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered with placebo. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (33 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVN424 75 mgParticipants will receive 75 mg CVN424 tablet once daily. | Drug | CVN424 75 mg |
| CVN424 150 mgParticipants will receive 150 mg CVN424 tablet once daily. | Drug | CVN424 150 mg |
| PlaceboParticipants will receive matching placebo tablet once daily. | Drug | Placebo |
Primary outcome
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
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.
18 secondary outcomes
Change from Baseline to Week 12 in the ON time without troublesome dyskinesia
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the Clinical Global Impression Scale - Severity (CGI-S)
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the Patient Global Impression Scale - Severity (PGI-S)
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the MDS-UPDRS Part III
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the Epworth Sleepiness Scale (ESS)
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 in the ON time with no dyskinesia
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the MDS-UPDRS Part I
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the Starkstein Apathy Scale (SAS)
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the CogState digital cognitive battery
Time frame: Baseline and Up to Week 12
Change from Baseline to Week 12 on the Schwab and England (S & E) Activities of Daily Living Scale (ADL)
Time frame: Baseline and Up to Week 12
Number of participants reporting treatment emergent adverse events (TEAEs), TEAEs related to moderate or severe intensity and leading to withdrawal of study drug
Time frame: Up to Week 14
Number of participants reporting serious adverse events (SAEs)
Time frame: Up to Week 14
Number of participants with suicidal ideation as measured by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 12
Number of participants with impulse control disorders as measured by the Questionnaire for Impulsive-Compulsive Disorders in Parkinson 's disease Rating Scale (QUIP-RS)
Time frame: Up to Week 12
Number of participants with clinically significant changes in physical examination, vital signs, electrocardiogram (ECG) finding, and laboratory values
Time frame: Up to Week 14
Percentage of completers
Time frame: Up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
94 sites in 9 countries: see every site and its status.
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.