8 completed. 5 Phase 2, 2 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 5 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
Follow olesoxime: new trials by email Literature Review of olesoxime trials Research Report on olesoxime
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA) Olesoxime - Muscular Atrophy, Spinal | Phase 2 | Completed | Hoffmann-La Roche | 131 | 2016-01-20 | 2019-08-09 |
| A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime) Olesoxime - Healthy Volunteer | Phase 1 | Completed | Hoffmann-La Roche | 6 | 2014-07-01 | 2016-07-18 |
| Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. olesoxime (TRO19622), placebo - Relapsing Remitting Multiple Sclerosis | Phase 1 | Completed | Hoffmann-La Roche | 44 | 2013-04-01 | 2016-11-22 |
| Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients. Olesoxime, Placebo - Spinal Muscular Atrophy Type II, Spinal Muscular Atrophy Type III Non Ambulant | Phase 2 | Completed | Hoffmann-La Roche | 165 | 2010-11-01 | 2016-11-22 |
| Safety Extension Study of TRO19622 in ALS TRO19622 - Amyotrophic Lateral Sclerosis | Phase 2 / Phase 3 | Completed | Hoffmann-La Roche | 271 | 2010-10-01 | 2016-11-22 |
| Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS Olesoxime, Placebo Comparator, Riluzole - Amyotrophic Lateral Sclerosis | Phase 3 | Completed | Hoffmann-La Roche | 512 | 2009-04-30 | 2020-02-25 |
| Effect of TRO19622 in the Treatment of Patients With Chemotherapy Induced Peripheral Neuropathy Olesoxime (TRO19622), Placebo Control - Chemotherapy-Induced Peripheral Neuropathy | Phase 2 | Completed | Hoffmann-La Roche | 17 | 2009-03-01 | 2016-11-22 |
| Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH) TRO19622, Placebo - Non-Alcoholic Steatohepatitis (NASH) | Phase 2 | Completed | Hoffmann-La Roche | 22 | 2008-04-15 | 2025-12-18 |
Amyotrophic Lateral Sclerosis (2) · Multiple Sclerosis (1) · Multiple Sclerosis, Relapsing-Remitting (1) · Muscular Atrophy, Spinal (1) · Non-alcoholic Fatty Liver Disease (1) · Spinal Muscular Atrophies of Childhood (1)
France (7) · Belgium (4) · Germany (4) · United Kingdom (4) · Italy (2) · Netherlands (2) · Poland (2) · Spain (2)
Enrico Bertini, MD (1) · Ivan Krakowski, MD (1) · Vincent Meininger, MD, PhD (1) · Vlad Ratziu, MD (1)
PMID 28460889, PMID 30814647, PMID 34433481, PMID 36288197
2014 (1), 2015 (1)