drugset / Trial / NCT02450552
Clinical Trial of Ezogabine (Retigabine) in ALS Subjects
Phase 2
Completed
65 enrolled
Brian Wainger
ALS Association · collabGlaxoSmithKline · collabHarvard University · collabMassachusetts General Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the effect of retigabine (600 mg/day, 900 mg/day, or placebo) on motor neuron activity in people with Amyotrophic Lateral Sclerosis (ALS). The total study duration is approximately 14 weeks. ALS subjects will take study drug for approximately 10 weeks.
Timeline
- Start
- 2015-06
- Primary completion
- 2018-01
- Completion
- 2018-02
Outcome
Met primary endpoint
paper The SICI-1 increased by 53% (mean ratio, 1.53; 95% CI, 1.12-2.09; P = .009) in the 900-mg/d ezogabine group vs placebo group. PMID 33226425 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezogabine | Small molecule | 600 mg | Oral |
| Subject | Ezogabine | Small molecule | 900 mg | Oral |