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

Parkinson Disease Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

The study will be conducted in three periods:

• Screening Period (up to 4 weeks) during which patient eligibility will be assessed;

• Double-blind Treatment Period (4 weeks) in which all patients will be randomized to receive placebo or Lenrispodun 30 mg/day in 1:1 ratio.

• Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT05766813
• Study type: Interventional
• Source: Intra-Cellular Therapies, Inc.
• Contact: ITI Clinical Trials
• Phone: 646-440-9333
• Email: ITCIClinicalTrials@itci-inc.com
• Status: Recruiting
• Phase: Phase 2
• Start date: March 13, 2023
• Completion date: February 2025