Gilenya in Amyotrophic Lateral Sclerosis (ALS)

NCT01786174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-07-01

Study results available
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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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Entities

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 NCT01786174 on ClinicalTrials.gov