A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)
Summary
A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Timeline
- Start
- 2011-06
- Primary completion
- 2016-07
- Completion
- 2016-07
Outcome
Met primary endpoint
release “positive top-line results from the pivotal Phase 3 clinical trial of Firdapse™” globenewswire.com ↗
release “Both co-primary endpoints, quantitative myasthenia gravis score (QMG) and subject global impression (SGI), demonstrated that Firdapse was significantly superior to placebo.” globenewswire.com ↗
release “The statistically significant and clinically relevant outcomes of primary and secondary endpoints of the Firdapse® pivotal Phase 3 trial” globenewswire.com ↗
release “In QMG score, placebo patients had a greater (2.2) worsening compared with Firdapse® (0.4) (p=0.0452).” globenewswire.com ↗
release “In SGI score, placebo patients had a greater worsening (-2.6) compared with Firdapse® (-0.8) (p=0.0028).” globenewswire.com ↗
release “pivotal Phase 3 trial resulting in positive top-line data on both co-primary endpoints.” globenewswire.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amifampridine | Small molecule | — | — |