drugset / Trial / NCT01808885
Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.
Phase 1
Completed
44 enrolled
Hoffmann-La Roche
Hôpital de la Timone · collabSGS S.A. · collabSTRAGEN Services · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.
Timeline
- Start
- 2013-04
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olesoxime | Small molecule | 495 mg | Oral |