At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
Safinamide Methanesulfonate +1 moredrug
Likely dose
Safinamide Methanesulfonate 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
12-weeks, Multicentre, Randomized, Double-blind, Placebo-controlled, Exploratory, Pilot Study to Evaluate the Safety and Efficacy of Safinamide 200 mg OD, as add-on Therapy, in Patients With Possible or Probable Parkinsonian Variant of MSA
In Brief
A Phase 2 clinical trial evaluating Safinamide Methanesulfonate and Safinamide Methanesulfonate matching placebo for Multiple System Atrophy. Completed, enrolled 49 participants across 19 sites in 2 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple System Atrophy
CountriesItaly, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartOct 2019
Primary CompletionJan 2021
TodayJul 2026
First PostedNov 27, 2018
Enrollment StartOct 29, 2019
Primary CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.6 years ago
Interventions
Safinamide Methanesulfonatedrug
100 mg (free base)
Safinamide Methanesulfonate matching placebodrug
100 mg placebo