Gilenya in Amyotrophic Lateral Sclerosis (ALS)
NCT01786174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2016-07-01
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).
Conditions
Interventions
- DRUG
-
Gilenya
0.5mg Gilenya orally by mouth once daily for approximately 28 days
- OTHER
-
Placebo
0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days
Sponsors & Collaborators
-
ALS Therapy Development Institute
collaborator OTHER -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
James D Berry, MD, MPH · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-08-31
- Primary Completion
- 2014-09-30
- Completion
- 2015-05-31
Countries
- United States
Study Locations
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