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

NCT03987750 Phase 3 WITHDRAWN

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.

Details

Lead sponsor	Zambon SpA
Phase	Phase 3
Status	WITHDRAWN
Start date	2019-10
Completion	2021-05

Conditions

• Dyskinesia, Drug-Induced
• Parkinson Disease

Interventions

• Safinamide Methanesulfonate 150mg
• Safinamide Methanesulfonate 100mg
• Safinamide Methanesulfonate matching placebo

Primary outcomes

• Assess the effect of two doses of safinamide on reducing levodopa-induced dyskinesia — 26 weeks
  Change from Baseline to Week 26 in levodopa-induced dyskinesia based on UDysRS total score. The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD