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

Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

• 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)

Locations
United States
Alabama
The Kirklin Clinic of UAB Hospital
RECRUITING
Birmingham
University of Alabama at Birmingham
RECRUITING
Birmingham
California
Parkinson's Research Centers of America - Palo Alto
RECRUITING
Palo Alto
Colorado
CenExel Rocky Mountain Clinical Research
RECRUITING
Englewood
Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
RECRUITING
Boca Raton
SFM Clinical Research, LLC
RECRUITING
Boca Raton
K2 Medical Research
RECRUITING
Maitland
Renstar Medical Research
RECRUITING
Ocala
N1 Research LLc
RECRUITING
Orlando
Parkinson's Disease Center of SWFL
RECRUITING
Port Charlotte
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - Brain & Spine Institute
RECRUITING
Port Orange
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
University of Kentucky, Dept of Neurology Kentucky Neuroscience Institute Research
RECRUITING
Lexington
Massachusetts
Boston Clinical Trials
RECRUITING
Boston
Michigan
University of Michigan Dept. of Neurology
RECRUITING
Ann Arbor
University of Michigan Hospital - Michigan Clinical Research Unit (MCRU)
RECRUITING
Ann Arbor
Quest Research Institute
RECRUITING
Farmington Hills
North Carolina
Duke Neurology Morreene Road Clinic
RECRUITING
Durham
Raleigh Neurology Associates
RECRUITING
Raleigh
Velocity Clinical Research
RECRUITING
Raleigh
New Jersey
Boro Neurology
RECRUITING
Hopewell
New York
Parkinson's Research Centers of America - Long Island
RECRUITING
Commack
Weill Cornell Medical College
RECRUITING
New York
Ohio
Riverhills Healthcare, Inc dba Riverhills Neuroscience
RECRUITING
Cincinnati
The Ohio State University - Martha Morehouse Medical Plaza
RECRUITING
Columbus
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Oklahoma
The Movement Disorder Clinic of Oklahoma
RECRUITING
Tulsa
Tennessee
Veracity Neuroscience LLC
RECRUITING
Memphis
Texas
Horizon Clinical Research Group
RECRUITING
Cypress
Texas Movement Disorder Specialists, PLLC
RECRUITING
Georgetown
Gill Neuroscience
RECRUITING
Houston
Houston Methodist Neurological Institute
RECRUITING
Houston
Central Texas Neurology Consultants
RECRUITING
Round Rock
Virginia
Inova Neurology - Fairfax
RECRUITING
Fairfax
Inova Fairfax Medical Campus
RECRUITING
Falls Church
Henrico Doctors Neurology Associates, LLC
RECRUITING
Richmond
Washington
Inland Northwest Research
RECRUITING
Spokane
Wisconsin
Medical College of Wisconsin-Department of Neurology
RECRUITING
Milwaukee
Other Locations
Australia
Southern Neurology
RECRUITING
Kogarah
Perron Institute for Neurological and Translational Science
RECRUITING
Nedlands
Westmead Hospital-Department of Neurology
RECRUITING
Sydney
Contact Information
Primary
Celina Scholl
clinicaltrials@cerevance.com
Backup
Clinical Team
clinicaltrials@cerevance.com
617-744-2315
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2026-03
Participants
Target number of participants: 330
Treatments
Experimental: CVN424 75 mg
Participants will be administered with oral doses of 75 mg CVN424.
Experimental: CVN424 150 mg
Participants will be administered with oral doses of 150 mg CVN424.
Placebo_comparator: Placebo
Participants will be administered with placebo.
Related Therapeutic Areas
Sponsors
Leads: Cerevance

This content was sourced from clinicaltrials.gov