NCT05766813

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Lenrispodun	Lenrispodun 30 mg tablets administered orally, once daily.
DRUG	Placebo	Matching tablets administered orally, once daily.

Timeline

• Start date: 2023-03-13
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2023-03-13
• Last updated: 2024-10-23

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study