drugset / Trial / NCT02496767
Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year
RandomizedParallel-groupTriple-blindTreatment
Summary
This study assessed the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.
Timeline
- Start
- 2015-09-03
- Primary completion
- 2017-03-09
- Completion
- 2017-09-27
Outcome
Missed primary endpoint
registry Group 1 - Placebo vs Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv; p = 0.3782; Least squares mean difference 1.707 NCT02496767 ↗
registry Group 1 - Placebo vs Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv; p = 0.7625; Least squares mean difference 0.612 NCT02496767 ↗
registry Group 1 - Placebo vs Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv; p = 0.8394; Least squares mean difference 0.428 NCT02496767 ↗
Publications
- Simkins TJ, Kupfer S, Malik FI, Meng L, Rudnicki SA, Wei J, Shefner JM, Bowser R. Plasma neurofilament analysis in VITALITY-ALS. Amyotroph Lateral Scler Frontotemporal Degener. 2025 Feb;26(1-2):103-112. doi: 10.1080/21678421.2024.2423707. Epub 2024 Nov 8.
- Andrews JA, Cudkowicz ME, Hardiman O, Meng L, Bian A, Lee J, Wolff AA, Malik FI, Shefner JM. VITALITY-ALS, a phase III trial of tirasemtiv, a selective fast skeletal muscle troponin activator, as a potential treatment for patients with amyotrophic lateral sclerosis: study design and baseline characteristics. Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):259-266. doi: 10.1080/21678421.2018.1426770. Epub 2018 Feb 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tirasemtiv | Other / unclassified | 250 mg | — |
| Subject | tirasemtiv | Other / unclassified | 375 mg | — |
| Subject | tirasemtiv | Other / unclassified | 500 mg | — |