drugset / Trial / NCT01786174
Gilenya in Amyotrophic Lateral Sclerosis (ALS)
Phase 2
Completed
30 enrolled
Massachusetts General Hospital
ALS Therapy Development Institute · collab
RandomizedParallel-groupQuadruple-blindTreatment
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).
Timeline
- Start
- 2013-08
- Primary completion
- 2014-09
- Completion
- 2015-05
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Gilenya (Fingolimod) vs Placebo; p = 0.780; Slope 0.25 (95% CI -1.53 to 2.03); Random slopes model NCT01786174 ↗
registry analysis (superiority or other test); Gilenya (Fingolimod) vs Placebo; p = 0.823; Slope -0.51 (95% CI -5.00 to 3.99); Random slopes model NCT01786174 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fingolimod | Small molecule | 0.5 mg | Oral |