RecruitingPhase 4NCT06765668

A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease

Open-Label Phase 4 Study of CREXONT® (Carbidopa and Levodopa) Extended Release Capsules in Parkinson's Disease Patients

Sponsor

Impax Laboratories, LLC

Enrollment

220 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying CREXONT, an extended-release capsule form of carbidopa/levodopa (the most common Parkinson's medication), to see how well it controls symptoms throughout the day and reduces the wearing-off periods where medication stops working. **You may be eligible if...** - You have been diagnosed with Parkinson's disease and are currently on a stable dose of carbidopa/levodopa (oral tablets) - You experience predictable off periods — times during the day when your medication stops working and your movement symptoms worsen - You have at least 2.5 hours per day of off time on average - Your motor symptoms are significant enough to be measured by standard rating scales **You may NOT be eligible if...** - Your Parkinson's symptoms are very severe or unpredictable - You are unable to swallow capsules - You have had recent changes to your Parkinson's medication regimen - You have significant cognitive impairment or other serious health conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCREXONT ER

CREXONT ER capsule.

Locations(27)

Barrow Neurological Institute

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Parkinson's Research Centers of America - Orange County

Aliso Viejo, California, United States

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, United States

Visionary Investigators Network

Aventura, Florida, United States

Parkinsons Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Univesity of Miami - Miller School of Medicine

Boca Raton, Florida, United States

University of Miami

Miami, Florida, United States

N1 Research LLC

Orlando, Florida, United States

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

Central DuPage Hospital - Movement Disorders Center

Winfield, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Parkinson's Research Centers of America - Long Island

Commack, New York, United States

Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower

Winston-Salem, North Carolina, United States

NeuroScience Research Center, LLC

Canton, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Neurology Consultants of Dallas, PA

Dallas, Texas, United States

Texas Movement Disorder Specialists, PLLC

Georgetown, Texas, United States

Icahn School of Medicine at Mount Sinai

Houston, Texas, United States

The University of Texas Health Science Center at Houston- McGovern Medical School

Houston, Texas, United States

Inova Neurology

Fairfax, Virginia, United States

VCU Parkinsons Disease and Movement Disorders Center

Henrico, Virginia, United States

MedStar Georgetown University Hospital Department of Neurology

McLean, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06765668

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