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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Cerevance
Sponsor
Cerevance
Information Provided by (Responsible Party)
Cerevance
Clinicaltrials.gov Identifier
NCT06553027
Other Study ID Numbers:
CVN424-301
First Submitted
August 8, 2024
First Posted
August 13, 2024
Last Update Posted
April 16, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Parkinson Disease
Drug: CVN424 75 mgDrug: CVN424 150 mgDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment330 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitlePhase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Complications
Study Start DateSeptember 19, 2024
Actual Primary Completion Date1mo 3w from now
Actual Study Completion Date1mo 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
CVN424 75 mg
Participants will be administered with oral doses of 75 mg CVN424.
Drug: CVN424 75 mg
Participants will receive 75 mg CVN424 tablet once daily.
CVN424 150 mg
Participants will be administered with oral doses of 150 mg CVN424.
Drug: CVN424 150 mg
Participants will receive 150 mg CVN424 tablet once daily.
Placebo
Participants will be administered with placebo.
Drug: Placebo
Participants will receive matching placebo tablet once daily.

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  13. Number of participants reporting treatment emergent adverse events (TEAEs), TEAEs related to moderate or severe intensity and leading to withdrawal of study drug
  14. Number of participants reporting serious adverse events (SAEs)
  15. Number of participants with suicidal ideation as measured by Columbia Suicide Severity Rating Scale (C-SSRS)
  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.
  17. Number of participants with clinically significant changes in physical examination, vital signs, electrocardiogram (ECG) finding, and laboratory values
  18. Percentage of completers

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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.
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)
Exclusion Criteria
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.
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.

Contacts and Locations

Sponsors and CollaboratorsCerevance
Locations
The Kirklin Clinic of UAB Hospital | Birmingham Alabama, United States, 35233University of Alabama at Birmingham | Birmingham Alabama, United States, 35233University of Alabama at Birmingham ALS Clinic | Birmingham Alabama, United States, 35294Barrow Neurological Institute | Phoenix Arizona, United States, 85013Muhammad Ali Parkinson Center | Phoenix Arizona, United States, 85013St. Joseph's Hospital and Medical Center | Phoenix Arizona, United States, 85013Parkinson's Research Centers of America - Orange county | Aliso Viejo California, United States, 92656Parkinson's Research Centers of America - Orange County | Newport Beach California, United States, 92663Parkinson's Research Centers of America - Palo Alto | Palo Alto California, United States, 94301CenExel Rocky Mountain Clinical Research | Englewood Colorado, United States, 80113David and Rhoda Chase Family Movement Disorders Center - Vernon | Vernon Connecticut, United States, 06066Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton Florida, United States, 33486SFM Clinical Research, LLC | Boca Raton Florida, United States, 33487K2 Medical Research | Maitland Florida, United States, 32751Renstar Medical Research | Ocala Florida, United States, 34471N1 Research LLc | Orlando Florida, United States, 32825Parkinson's Disease Center of SWFL | Port Charlotte Florida, United States, 33980University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute | Port Orange Florida, United States, 32127USF Parkinson's Disease and Movement Disorders Center | Tampa Florida, United States, 33613Atlanta Neuroscience Institute | Atlanta Georgia, United States, 30327University of Kansas Medical Center | Kansas City Kansas, United States, 66160University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research | Lexington Kentucky, United States, 40536Boston Clinical Trials | Boston Massachusetts, United States, 02131University of Michigan Dept. of Neurology | Ann Arbor Michigan, United States, 48109University of Michigan Hospital - Michigan Clinical Research Unit (MCRU) | Ann Arbor Michigan, United States, 48109Quest Research Institute | Farmington Hills Michigan, United States, 48334Boro Neurology | Hopewell New Jersey, United States, 08525Global Neurosciences Institute at Pennington | Pennington New Jersey, United States, 08534Parkinson's Research Centers of America - Long Island | Commack New York, United States, 11725Weill Cornell Medical College | New York New York, United States, 10021The Neurological Institute | Charlotte North Carolina, United States, 28204Duke Neurology Morreene Road Clinic | Durham North Carolina, United States, 27705Raleigh Neurology Associates | Raleigh North Carolina, United States, 27607Velocity Clinical Research | Raleigh North Carolina, United States, 27607Riverhills Healthcare, Inc dba Riverhills Neuroscience | Cincinnati Ohio, United States, 45212The Ohio State University Wexner Medical Center | Columbus Ohio, United States, 43210The Ohio State University - Martha Morehouse Medical Plaza | Columbus Ohio, United States, 43221The Movement Disorder Clinic of Oklahoma | Tulsa Oklahoma, United States, 74136Oregon Health and Science University | Portland Oregon, United States, 97239Medical University of South Carolina | Charleston South Carolina, United States, 29425Veracity Neuroscience LLC | Memphis Tennessee, United States, 38157Horizon Clinical Research Group | Cypress Texas, United States, 77429Texas Movement Disorder Specialists, PLLC | Georgetown Texas, United States, 78628Houston Methodist Neurological Institute | Houston Texas, United States, 77030Gill Neuroscience | Houston Texas, United States, 77065Central Texas Neurology Consultants | Round Rock Texas, United States, 78681Inova Parkinson's and Movement Disorders Center - Alexandria | Alexandria Virginia, United States, 22311Inova Neurology - Fairfax | Fairfax Virginia, United States, 22031Inova Fairfax Medical Campus | Falls Church Virginia, United States, 22042Henrico Doctors Neurology Associates, LLC | Richmond Virginia, United States, 23229EvergreenHealth Research Department | Kirkland Washington, United States, 98034Inland Northwest Research | Spokane Washington, United States, 99202Medical College of Wisconsin-Department of Neurology | Milwaukee Wisconsin, United States, 53226St Vincent's Hospital Sydney | Darlinghurst New South Wales, Australia, NSW 2010Southern Neurology | Kogarah New South Wales, Australia, NSW 2217Westmead Hospital-Department of Neurology | Sydney New South Wales, Australia, NSW 2145Princess Alexandra Hospital | Woolloongabba Queensland, Australia, QLD 4102Monash Health | Cheltenham Victoria, Australia, VIC 3192The Alfred | Melbourne Victoria, Australia, VIC 3004Perron Institute for Neurological and Translational Science | Nedlands Western Australia, Australia, WA 6009Nemocnice Pardubického kraje, a.s. - Pardubická nemocnice | Pardubičky Pardubice, Czechia, 530 03Vseobecna Fakultni Nemocnice v Praze | Prague Prague, Czechia, 128 08Praglandia s.r.o. | Prague Prague, Czechia, 150 00Axon Clinical s.r.o. | Prague Prague, Czechia, 150 06Fakultní Nemocnice u sv. Anny v Brně | Brno South Moravian, Czechia, 656 91Neurologie Taláb Radomír Doc. MUDr., CSc | Hradec Králové , Czechia, 500 03Vseobecna Fakultni Nemocnice v Praze | Prague , Czechia, 120 00Hôpital Pierre Wertheimer | Bron Auvergne-Rhône-Alpes, France, 69500Hôpital Pierre-Paul Riquet | Toulouse Haute-Garonne, France, 31059Hôpital Gui de Chauliac | Montpellier Hérault, France, 34295Hôpital Roger Salengro | Lille Nord, France, 59037Hôpitaux Universitaires Henri Mondor | Créteil Val-De-Marne, France, 94010San Raffaele Cassino | Cassino Frosinone, Italy, 03043Azienda Ospedale Università di Padova | Padova Padua, Italy, 35128Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana | Rome , Italy, 00163Centrum Zdrowia i Urody MAXXMED | Lublin Lublin Voivodeship, Poland, 20-080ETG Neuroscience Sp. z o. o | Warsaw Masovian Voivodeship, Poland, 02-677Neuro-Care Centrum Medyczne | Katowice Silesian Voivodeship, Poland, 40-001Neurologia Śląska Centrum Medyczne | Katowice Silesian Voivodeship, Poland, 40-123Wielospecjalistyczna Poradnia Lekarska Synapsis | Katowice Silesian Voivodeship, Poland, 40-123The Alliance Hispanic Alliance for Clinical and Translational Research | Rio Piedras , Puerto Rico, 00935Universidad de Puerto Rico Recinto de Ciencias Médicas | San Juan , Puerto Rico, 00936-5067Hospital Universitario Virgen del Rocío | Seville Andalusia, Spain, 41013Hospital Universitari General de Catalunya | Sant Cugat del Vallès Barcelona, Spain, 08190Hospital Universitario Cruces | Barakaldo Biscay, Spain, 48903Policlínica Gipuzkoa | San Sebastián Gipuzkoa, Spain, 20014Hospital Universitari i Politècnic La Fe | Valencia Valenciana, Comunidad, Spain, 46026Hospital Clinic de Barcelona | Barcelona , Spain, 08036Hospital de la Santa Creu i Sant Pau | Barcelona , Spain, 08041Hospital Universitario de La Princesa | Madrid , Spain, 28006Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne England, United Kingdom, NE4 5PLNorthern Care Alliance NHS Foundation Trust | Bury , United Kingdom, BL9 7TDKing's College Hospital NHS Foundation Trust | London , United Kingdom, SE5 9RSUniversity Hospitals Plymouth NHS Trust | Plymouth , United Kingdom, PL6 8BU