RecruitingPhase 2NCT05766813

Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease

A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease


Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

132 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing lenrispodun, a new add-on medication, for people with Parkinson's disease who experience "off" periods — times when their levodopa medication wears off and symptoms like tremors, stiffness, or slowness return before the next dose. **You may be eligible if...** - You are 40 years old or older - You have a confirmed diagnosis of Parkinson's disease - You are currently on a stable, adequate dose of levodopa and it works for you, but you experience "off" periods - Your disease is at stage 2 or 3 (moderate) **You may NOT be eligible if...** - Your Parkinson's symptoms don't respond to levodopa - You are on very low doses of levodopa - You have conditions that could interfere with the study medication 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

DRUGLenrispodun

Lenrispodun 30 mg tablets administered orally, once daily.

DRUGPlacebo

Matching tablets administered orally, once daily.


Locations(31)

Clinical Site

Phoenix, Arizona, United States

Clinical Site

Scottsdale, Arizona, United States

Clinical Site

Irvine, California, United States

Clinical Site

Loma Linda, California, United States

Clinical Site

Altamonte Springs, Florida, United States

Clinical Site

Boca Raton, Florida, United States

Clinical Site

Coral Springs, Florida, United States

Clinical Site

Hallandale, Florida, United States

Clinical Site

Maitland, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Ocala, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site

Port Orange, Florida, United States

Clinical Site

Tampa, Florida, United States

Clinical Site

Augusta, Georgia, United States

Clinical Site

Decatur, Georgia, United States

Clinical Site

Kansas City, Kansas, United States

Clinical Site

Farmington Hills, Michigan, United States

Clinical Site

Golden Valley, Minnesota, United States

Clinical Site

Albany, New York, United States

Clinical Site

Rock Hill, South Carolina, United States

Clinical Site

Memphis, Tennessee, United States

Clinical Site

Austin, Texas, United States

Clinical Site

Dallas, Texas, United States

Clinical Site

Georgetown, Texas, United States

Clinical Site

Falls Church, Virginia, United States

Clinical Site

Henrico, Virginia, United States

Clinical Site

Kirkland, Washington, United States

Clinical Site

Spokane, Washington, United States

Clinical Site

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05766813


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