NCT03987750

Safinamide for Levodopa-induced Dyskinesia (PD-LID)

A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor Fluctuations

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Zambon SpA · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, multi-center, randomized, double-blind, parallel group, placebo-controlled study, in participants with PD who are on a stable regimen of dopaminergic medication and have at least mild levodopa-induced dyskinesia. Eligible participants will be randomized to one of three treatment groups to receive adjunctive daily treatment with either safinamide 100 mg, safinamide 150 mg or placebo in a 1:1:1 ratio. Outcome will be assessed after 26 weeks of treatment.

Detailed description

Trial participation will be up to a maximum duration of 32 weeks and will comprise: * Screening period (up to 4 weeks) for screening assessments; * Two weeks titration period: participants randomized to the 100 mg study arm will receive 100 mg during Week 1 and throughout the rest of the study; participants randomized to the 150 mg study arm will receive 100 mg during Weeks 1 and 2 , and 150 mg from Week 3 and throughout the rest of the study; participants randomized to the placebo arm will receive identical placebo tablets. * Twenty-four weeks maintenance period during which patients receive their randomized treatment as an adjunct to their standard anti-PD medications, which should remain unaltered. End of treatment evaluations will be performed at the end of Week 26 or at early discontinuation * A telephone follow-up call will be performed 2 weeks after the end of treatment to assess adverse events and concomitant medications

Conditions

• Dyskinesia, Drug-Induced
• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Safinamide Methanesulfonate 150mg	150 mg (free base)
DRUG	Safinamide Methanesulfonate 100mg	100 mg (free base)
DRUG	Safinamide Methanesulfonate matching placebo	placebo

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-04-01
• Completion: 2021-05-01
• First posted: 2019-06-17
• Last updated: 2020-06-17

Regulatory

• FDA-regulated drug study