drugset / Trial / NCT00868166
Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS
RandomizedParallel-groupQuadruple-blindOther
Summary
The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month survival rate.
Timeline
- Start
- 2009-04-30
- Primary completion
- 2011-09-30
- Completion
- 2011-09-30
Outcome
Missed primary endpoint
registry NUMBER Olesoxime: 67.5 (61.0 to 73.1) percentage of partcipants NCT00868166 ↗
registry NUMBER Placebo Comparator: 69.4 (63.0 to 74.9) percentage of partcipants NCT00868166 ↗
registry analysis (superiority test); Olesoxime vs Placebo Comparator; p = 0.71; Stratified Log-Rank Test NCT00868166 ↗
Publications
- Witzel S, Frauhammer F, Steinacker P, Devos D, Pradat PF, Meininger V, Halbgebauer S, Oeckl P, Schuster J, Anders S, Dorst J, Otto M, Ludolph AC. Neurofilament light and heterogeneity of disease progression in amyotrophic lateral sclerosis: development and validation of a prediction model to improve interventional trials. Transl Neurodegener. 2021 Aug 26;10(1):31. doi: 10.1186/s40035-021-00257-y.
- Devos D, Moreau C, Kyheng M, Garcon G, Rolland AS, Blasco H, Gele P, Timothee Lenglet T, Veyrat-Durebex C, Corcia P, Dutheil M, Bede P, Jeromin A, Oeckl P, Otto M, Meininger V, Danel-Brunaud V, Devedjian JC, Duce JA, Pradat PF. A ferroptosis-based panel of prognostic biomarkers for Amyotrophic Lateral Sclerosis. Sci Rep. 2019 Feb 27;9(1):2918. doi: 10.1038/s41598-019-39739-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olesoxime | Small molecule | 330 mg | Oral |
| Background | Riluzole | Small molecule | 50 mg | — |