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Safinamide for Multiple System Atrophy (MSA)

NCT03753763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-10-13

Study results available
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Summary

The study is a placebo controlled study, with two parallel arms, in which participants will be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo in a double blind manner. Study population is patients diagnosed, with possible or probable parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa

Conditions

Interventions

DRUG

Safinamide Methanesulfonate

100 mg (free base)

DRUG

Safinamide Methanesulfonate matching placebo

100 mg 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
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-29
Primary Completion
2021-01-05
Completion
2021-01-05

Countries

  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT03753763 on ClinicalTrials.gov