Olesoxime

Generic Name: Olesoxime

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₄₅NO

CAS Number: 22033-87-0

Unique Ingredient Identifier: 8V8EF6094N

Background: Olesoxime is a cholesterol-like small molecule that has demonstrated a remarkable neuroprotective profile in a battery of both in vitro and in vivo preclinical models. For example, it has demonstrated the ability to prevent neurodegeneration, enhance nerve function and accelerate neuroregeneration following nerve trauma.

Indication: Investigated for use/treatment in neurologic disorders.

Clinical Trials

A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime)

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Olesoxime

First Posted Date: 2016-07-18

Last Posted Date: 2016-07-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 6

Registration Number: NCT02835976

A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)

Phase 2

Completed

Conditions: Muscular Atrophy, Spinal

Interventions: Drug: Olesoxime

First Posted Date: 2015-12-11

Last Posted Date: 2019-08-09

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 131

Registration Number: NCT02628743

Locations: 🇫🇷
Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique - L'ESCALE, Bron, France
🇫🇷
Hôpital Raymond Poincare; Serv. Neurologie et Réanimation pédiatriques - Centre réf. neuromusculaire, Garches, France
🇫🇷
Hopital Jeanne De Flandre; CIC pediatrique, Lille, France

and more 21 locations

Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.

Phase 1

Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Drug: olesoxime (TRO19622)
Drug: placebo

First Posted Date: 2013-03-11

Last Posted Date: 2016-11-22

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 44

Registration Number: NCT01808885

Locations: 🇫🇷
Timone University Hospital, Neurology Department, UMR CRMBM CNRS 6612, Marseille, France
🇫🇷
CHU Pontchaillou, Neurology Department, Rennes, France
🇫🇷
CHU Reims, Maison Blanche Hospital, Neurology Department & University of Reims, Reims, France

Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients.

Phase 2

Completed

Conditions: Spinal Muscular Atrophy Type II
Spinal Muscular Atrophy Type III Non Ambulant

Interventions: Drug: Placebo
Drug: Olesoxime

First Posted Date: 2011-02-24

Last Posted Date: 2016-11-22

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 165

Registration Number: NCT01302600

Locations: 🇫🇷
Hôpital Raymond Poincaré, Garches, France
🇫🇷
Hôpital Femme-Mère-Enfant, Bron, France
🇩🇪
University of Essen, Essen, Germany

and more 18 locations

Safety Extension Study of TRO19622 in ALS

Phase 2

Completed

Conditions: Amyotrophic Lateral Sclerosis

Interventions: Drug: TRO19622

First Posted Date: 2011-01-28

Last Posted Date: 2016-11-22

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 271

Registration Number: NCT01285583

Locations: 🇫🇷
CHRU de LILLE - Hôpital Roger Salengro - Centre SLA-MMN - Sce de Neurologie et Pathologie du Mouvement, Lille, France
🇫🇷
HCL Hôpital Neurologique et Neurochirurgical Pierre Wertheimer - Neurologie C et Laboratoire d'électromyographie - 59, boulevard Pinel, Bron Cedex, France
🇫🇷
Clinique du Motoneurone - Sce d'Explorations Neurologiques - Hôpital Gui de Chauliac, Montpellier, France

and more 12 locations

Effect of TRO19622 in the Treatment of Patients With Chemotherapy Induced Peripheral Neuropathy

Phase 2

Completed

Conditions: Chemotherapy-Induced Peripheral Neuropathy

Interventions: Drug: Olesoxime (TRO19622)
Drug: Placebo Control

First Posted Date: 2009-04-06

Last Posted Date: 2016-11-22

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 17

Registration Number: NCT00876538

Locations: 🇫🇷
Centre Antoine Lacassagne, Nice, France
🇫🇷
C.R.L.C Val d'Aurelle Service d'Oncologie Médicale, Montpellier, France
🇫🇷
Centre Hospitalier de Versailles Hôpital André Mignot Service d'Hématologie-Oncologie, Le Chesnay, France

and more 5 locations

Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS

Phase 3

Completed

Conditions: Amyotrophic Lateral Sclerosis

Interventions: Drug: Olesoxime
Drug: Placebo Comparator
Drug: Riluzole

First Posted Date: 2009-03-24

Last Posted Date: 2020-02-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 512

Registration Number: NCT00868166

Locations: 🇧🇪
University Hospital Gasthuisberg - Dept Neurology - Herestraat 49, Leuven, Belgium
🇫🇷
Hôpital La Timone - Service Neurologie et Maladies Neuromusculaires, Marseille, France
🇫🇷
Clinique du Motoneurone - Sce d'Explorations Neurologiques - Hôpital Gui de Chauliac, Montpellier, France

and more 12 locations

Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH)

Phase 2

Completed

Conditions: Non-Alcoholic Steatohepatitis (NASH)

Interventions: Drug: TRO19622

First Posted Date: 2008-04-24

Last Posted Date: 2016-11-22

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 35

Registration Number: NCT00666016

Locations: 🇫🇷
Hôpital Archet 2 - Pôle de Référence Hépatite C (Niveau -2) - 151, route Saint Antoine de Ginestière, Nice, France
🇫🇷
Groupe Hospitalier Pitié-Salpétrière - Sce Hépato-Gastroentérologie - 47-83 Bd de l'Hôpital, Paris, France

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