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Quick Info
Status
This study has been completed
Estimated Enrollment
30
Phase
II
Treatment Type
orally available
Trial Type
Double-Blind, Placebo-Controlled
Primary Investigator
James D Berry, MD, MPH Massachusetts General Hospital
Contact Information
Locations
United States, California
University of California, Irvine, Orange, CA, 92868, United States
United States, Georgia
Georgia Regents University, Augusta, GA, 30912, United States
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
United States, Texas
Methodist Neurological Institute, Houston, TX, 77030, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
>65%
Months Since Onset
Number of months since first symptoms of ALS.
<24
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
No
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
No
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Update Notes
Study completed
9/23/2015
No significant updates.
4/13/2015
Recruitment status updated.
12/9/2014
No significant updates.
4/14/2014
No significant updates.
2/3/2014
Recruitment status updated
1/24/2014
All recruitment sites currently recruiting
11/13/2013
Location recruitment status updated
10/11/2013
GA location and contact information updated
8/21/2013
This study has one site currently recruiting.
8/9/2013
Enrollment criteria added.
3/27/2013
Trial added.
2/7/2013

Other Information

Purpose
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).
Eligibility
18 years and older. Both genders. No healthy volunteers.
Details
The primary objective of the study is to determine the acute safety and tolerability of oral administration of Gilenya (fingolimod) 0.5mg daily vs. matched oral placebo administered daily. The primary outcome measure will be safety and tolerability; safety will be assessed by the occurrence of adverse events and clinically meaningful changes in vital signs, ophthalmologic examination, physical examination, electrocardiogram and standard clinical laboratory blood tests, and tolerability will be defined as the ability of subjects to complete the entire 4-week study. The secondary outcome measure will be the measured effect of the treatment on circulating lymphocyte populations in patients with ALS. Exploratory outcome measures will include the rate of decline of the ALS Functional Rating Scale (Revised) (ALSFRS-R) and Slow Vital Capacity (VC) during the course of treatment. This study will be conducted in subjects who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. At screening, eligible subjects must be at least 18 years old, must have an SVC ≥ 65% of predicted capacity for age, height and gender, and must provide written informed consent prior to screening. Subjects on a stable dose of riluzole and those not taking riluzole, and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. Subjects will remain on randomized, placebo-controlled, double-blind treatment until the Week 4 visit. Each randomized subject will also have a Week 8 Follow-up Telephone Interview to assess for adverse events (AEs), changes in concomitant medications and to administer the ALSFRS-R.
News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT01786174 (First Published: 2/4/2013)