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Safinamide for Levodopa-induced Dyskinesia (PD-LID)

NCT03987750 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-06-17

No results posted yet for this study

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.

Conditions

  • Dyskinesia, Drug-Induced
  • Parkinson Disease

Interventions

DRUG

Safinamide Methanesulfonate 150mg

150 mg (free base)

DRUG

Safinamide Methanesulfonate 100mg

100 mg (free base)

DRUG

Safinamide Methanesulfonate matching placebo

placebo

Sponsors & Collaborators

  • Zambon SpA

    lead INDUSTRY

Principal Investigators

  • Charlotte Keywood, MD · Zambon SpA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2021-04-30
Completion
2021-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03987750 on ClinicalTrials.gov