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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: CVN424 75 mg; Drug: CVN424 150 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will be administered with placebo.	Drug: Placebo; Participants will receive matching placebo tablet once daily.
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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		Up to Week 14
Number of participants reporting serious adverse events (SAEs)		Up to Week 14
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.	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.	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.	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.	Baseline and Up to Week 12
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.	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.	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.	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.	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.	Baseline and Up to Week 12
Number of participants with suicidal ideation as measured by Columbia Suicide Severity Rating Scale (C-SSRS)		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.	Up to Week 12
Number of participants with clinically significant changes in physical examination, vital signs, electrocardiogram (ECG) finding, and laboratory values		Up to Week 14
Percentage of completers		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.	Baseline and Up to Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach Cmax of CVN424		At Day 1, Week 2, Week 4, Week 8, and Week 12
Area under the plasma concentration-time curve from time 0 (time of dosing) to last time of sample collection hours (AUC 0-last) of CVN424		At Day 1, Week 2, Week 4, Week 8, and Week 12
Half-life (t1/2) of CVN424		At Day 1, Week 2, Week 4, Week 8, and Week 12
Change from Baseline on the Modality virtual assessments	The Modality System is an artificial intelligence interface designed to collect information on clinical performance through audio-visual conversational technology. Participants will engage with a virtual agent via a web browser on their electronic device, completing assessments aimed at testing various functions including speech, visuo-motor skills, prosodic (stress and intonation patterns), cognitive, and linguistic abilities.	Baseline and Up to Week 14
Maximum observed plasma concentration (Cmax) of CVN424		At Day 1, Week 2, Week 4, Week 8, and Week 12

Collaborators and Investigators

• Sponsor: Cerevance

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson Disease; Phase 3; Motor fluctuations; Idiopathic Parkinson Disease; CVN424
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: CVN424-301; 2024-516811-25-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No