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

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Male or female between 40 years of age and older

• Body mass index of 19.0-40.0 kg/m2;

• Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria;

• Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state;

• Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:

‣ Have been on a stable and optimal dose of levodopa (levodopa + DDCI combination: minimum dose of levodopa equivalent to 100 mg three times daily) for at least 4 weeks prior to Screening, and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;

⁃ If taking other anti-parkinsonian medications (MAO-B \[monoamine oxidase B\] inhibitor, COMT \[catechol-O-methyltransferase\] inhibitor, dopamine agonist) in addition to levodopa, have been on a stable dose for at least 4 weeks prior to Screening and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;

∙ 7\. Have wearing-off symptoms and levodopa-induced dyskinesia as per Investigator judgment; 8. Properly complete and return a self-reported home diary for motor function status (Hauser Diary) during the Screening Period, which confirms 3 days (ie, 3 consecutive, 24-hour periods) immediately prior to Baseline, each with at least 2½ hours of OFF time during waking hours.

∙ 9\. Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.

Locations
United States
Arizona
Clinical Site
RECRUITING
Phoenix
Clinical Site
RECRUITING
Scottsdale
California
Clinical Site
RECRUITING
Irvine
Clinical Site
RECRUITING
Loma Linda
Florida
Clinical Site
RECRUITING
Altamonte Springs
Clinical Site
RECRUITING
Boca Raton
Clinical Site
RECRUITING
Coral Springs
Clinical Site
RECRUITING
Hallandale
Clinical Site
NOT_YET_RECRUITING
Maitland
Clinical Site
RECRUITING
Miami
Clinical Site
RECRUITING
Ocala
Clinical Site
RECRUITING
Orlando
Clinical Site
RECRUITING
Orlando
Clinical Site
RECRUITING
Port Orange
Clinical Site
RECRUITING
Tampa
Georgia
Clinical Site
RECRUITING
Augusta
Clinical Site
RECRUITING
Decatur
Kansas
Clinical Site
RECRUITING
Kansas City
Michigan
Clinical Site
RECRUITING
Farmington Hills
Minnesota
Clinical Site
RECRUITING
Golden Valley
New York
Clinical Site
NOT_YET_RECRUITING
Albany
South Carolina
Clinical Site
RECRUITING
Rock Hill
Tennessee
Clinical Site
RECRUITING
Memphis
Texas
Clinical Site
RECRUITING
Austin
Clinical Site
RECRUITING
Dallas
Clinical Site
RECRUITING
Georgetown
Virginia
Clinical Site
RECRUITING
Falls Church
Clinical Site
RECRUITING
Henrico
Washington
Clinical Site
RECRUITING
Kirkland
Clinical Site
RECRUITING
Spokane
Wisconsin
Clinical Site
RECRUITING
Milwaukee
Contact Information
Primary
ITI Clinical Trials
ITCIClinicalTrials@itci-inc.com
646-440-9333
Time Frame
Start Date: 2023-03-13
Estimated Completion Date: 2025-10
Participants
Target number of participants: 132
Treatments
Experimental: Lenrispodun 30 mg
Lenrispodun 30 mg tablets administered orally, once-daily.
Placebo_comparator: Placebo
Matching tablets administered orally, once daily.
Sponsors
Leads: Intra-Cellular Therapies, Inc.

This content was sourced from clinicaltrials.gov