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

NCT06553027 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CVN424-3012024-516811-25-00
• Study Type: interventional
• Target: 330
• Locations: 9 countries
• Sites: 94

Brief 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. 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

Keywords

Parkinson Disease; CVN424; Phase 3; Motor fluctuations; Idiopathic Parkinson Disease

Outcome Measures

Primary Outcomes (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.

  Baseline and Up to Week 12

Secondary Outcomes (18)

• Change from Baseline to Week 12 in the ON time without troublesome dyskinesia

  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

  Baseline and Up to Week 12

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

  Baseline and Up to Week 12

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

  Baseline and Up to Week 12

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

  Baseline and Up to Week 12

Other Outcomes (5)

• Maximum observed plasma concentration (Cmax) of CVN424

  At Day 1, Week 2, Week 4, Week 8, and Week 12

• 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

Study Arms (3)

CVN424 75 mg

EXPERIMENTAL

Participants will be administered with oral doses of 75 mg CVN424.

Drug: CVN424 75 mg

CVN424 150 mg

EXPERIMENTAL

Participants will be administered with oral doses of 150 mg CVN424.

Drug: CVN424 150 mg

Placebo

PLACEBO COMPARATOR

Participants will be administered with placebo.

Drug: Placebo

Interventions

CVN424 75 mg DRUG

Participants will receive 75 mg CVN424 tablet once daily.

CVN424 75 mg

CVN424 150 mg DRUG

Participants will receive 150 mg CVN424 tablet once daily.

CVN424 150 mg

Placebo DRUG

Participants will receive matching placebo tablet once daily.

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerevance: lead

Study Sites (94)

The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham ALS Clinic

Birmingham, Alabama, 35294, United States

Location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Muhammad Ali Parkinson Center

Phoenix, Arizona, 85013, United States

Location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Parkinson's Research Centers of America - Orange county

Aliso Viejo, California, 92656, United States

Location

Parkinson's Research Centers of America - Orange County

Newport Beach, California, 92663, United States

Location

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, 94301, United States

Location

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States

Location

David and Rhoda Chase Family Movement Disorders Center - Vernon

Vernon, Connecticut, 06066, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

SFM Clinical Research, LLC

Boca Raton, Florida, 33487, United States

Location

K2 Medical Research

Maitland, Florida, 32751, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

N1 Research LLc

Orlando, Florida, 32825, United States

Location

Parkinson's Disease Center of SWFL

Port Charlotte, Florida, 33980, United States

Location

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

Port Orange, Florida, 32127, United States

Location

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

Location

Atlanta Neuroscience Institute

Atlanta, Georgia, 30327, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research

Lexington, Kentucky, 40536, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

University of Michigan Dept. of Neurology

Ann Arbor, Michigan, 48109, United States

Location

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

Ann Arbor, Michigan, 48109, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Boro Neurology

Hopewell, New Jersey, 08525, United States

Location

Global Neurosciences Institute at Pennington

Pennington, New Jersey, 08534, United States

Location

Parkinson's Research Centers of America - Long Island

Commack, New York, 11725, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

The Neurological Institute

Charlotte, North Carolina, 28204, United States

Location

Duke Neurology Morreene Road Clinic

Durham, North Carolina, 27705, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Velocity Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Riverhills Healthcare, Inc dba Riverhills Neuroscience

Cincinnati, Ohio, 45212, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

The Ohio State University - Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States

Location

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Veracity Neuroscience LLC

Memphis, Tennessee, 38157, United States

Location

Horizon Clinical Research Group

Cypress, Texas, 77429, United States

Location

Texas Movement Disorder Specialists, PLLC

Georgetown, Texas, 78628, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

Gill Neuroscience

Houston, Texas, 77065, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Inova Parkinson's and Movement Disorders Center - Alexandria

Alexandria, Virginia, 22311, United States

Location

Inova Neurology - Fairfax

Fairfax, Virginia, 22031, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Henrico Doctors Neurology Associates, LLC

Richmond, Virginia, 23229, United States

Location

EvergreenHealth Research Department

Kirkland, Washington, 98034, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Medical College of Wisconsin-Department of Neurology

Milwaukee, Wisconsin, 53226, United States

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, NSW 2010, Australia

Location

Southern Neurology

Kogarah, New South Wales, NSW 2217, Australia

Location

Westmead Hospital-Department of Neurology

Sydney, New South Wales, NSW 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, QLD 4102, Australia

Location

Monash Health

Cheltenham, Victoria, VIC 3192, Australia

Location

The Alfred

Melbourne, Victoria, VIC 3004, Australia

Location

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, WA 6009, Australia

Location

Nemocnice Pardubického kraje, a.s. - Pardubická nemocnice

Pardubičky, Pardubice, 530 03, Czechia

Location

Vseobecna Fakultni Nemocnice v Praze

Prague, Prague, 128 08, Czechia

Location

Praglandia s.r.o.

Prague, Prague, 150 00, Czechia

Location

Axon Clinical s.r.o.

Prague, Prague, 150 06, Czechia

Location

Fakultní Nemocnice u sv. Anny v Brně

Brno, South Moravian, 656 91, Czechia

Location

Neurologie Taláb Radomír Doc. MUDr., CSc

Hradec Králové, 500 03, Czechia

Location

Vseobecna Fakultni Nemocnice v Praze

Prague, 120 00, Czechia

Location

Hôpital Pierre Wertheimer

Bron, Auvergne-Rhône-Alpes, 69500, France

Location

Hôpital Pierre-Paul Riquet

Toulouse, Haute-Garonne, 31059, France

Location

Hôpital Gui de Chauliac

Montpellier, Hérault, 34295, France

Location

Hôpital Roger Salengro

Lille, Nord, 59037, France

Location

Hôpitaux Universitaires Henri Mondor

Créteil, Val-De-Marne, 94010, France

Location

San Raffaele Cassino

Cassino, Frosinone, 03043, Italy

Location

Azienda Ospedale Università di Padova

Padova, Padua, 35128, Italy

Location

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

Rome, 00163, Italy

Location

Centrum Zdrowia i Urody MAXXMED

Lublin, Lublin Voivodeship, 20-080, Poland

Location

ETG Neuroscience Sp. z o. o

Warsaw, Masovian Voivodeship, 02-677, Poland

Location

Neuro-Care Centrum Medyczne

Katowice, Silesian Voivodeship, 40-001, Poland

Location

Neurologia Śląska Centrum Medyczne

Katowice, Silesian Voivodeship, 40-123, Poland

Location

Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, Silesian Voivodeship, 40-123, Poland

Location

The Alliance Hispanic Alliance for Clinical and Translational Research

Rio Piedras, 00935, Puerto Rico

Location

Universidad de Puerto Rico Recinto de Ciencias Médicas

San Juan, 00936-5067, Puerto Rico

Location

Hospital Universitario Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, 08190, Spain

Location

Hospital Universitario Cruces

Barakaldo, Biscay, 48903, Spain

Location

Policlínica Gipuzkoa

San Sebastián, Gipuzkoa, 20014, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Valenciana, Comunidad, 46026, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, England, NE4 5PL, United Kingdom

Location

Northern Care Alliance NHS Foundation Trust

Bury, BL9 7TD, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

University Hospitals Plymouth NHS Trust

Plymouth, PL6 8BU, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 14, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PR (2); AU (7); US (53); CZ (7); IT (3); PL (5); ES (8); GB (4); FR (5)