At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Gilenya +1 moredrug
Likely dose
Gilenya 0.5mgfrom 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.
Phase IIa Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Oral Fingolimod in Patients With Amyotrophic Lateral Sclerosis (ALS)
In Brief
A Phase 2 clinical trial evaluating Gilenya and Placebo for Amyotrophic Lateral Sclerosis. Completed, enrolled 30 participants across 4 sites.
Detailed Summary
The purpose of this study is to determine whether Gilenya, also known as fingolimod, is safe and tolerable in patients with Amyotrophic Lateral Sclerosis (ALS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesUnited States
CollaboratorsALS Therapy Development Institute
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartAug 2013
Primary CompletionSep 2014
Study CompletionMay 2015
TodayJul 2026
First PostedFeb 7, 2013
Enrollment StartAug 1, 2013
Primary CompletionSep 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.4 years ago
Interventions
Gilenyadrug
0.5mg Gilenya orally by mouth once daily for approximately 28 days
Placeboother
0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days