drugset / Trial / NCT03987750

Safinamide for Levodopa-induced Dyskinesia (PD-LID)

NCT03987750

Phase 3 Withdrawn Zambon SpA
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-10
Primary completion
2021-04
Completion
2021-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Safinamide Small molecule 100 mg
Subject Safinamide Small molecule 150 mg