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

NCT01808885 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-11-22

No results posted yet for this study

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.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

olesoxime (TRO19622)

olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months. Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit).

DRUG

placebo

placebo capsule shells with identical appearance as the active compound TRO19622

Sponsors & Collaborators

  • Hôpital de la Timone

    collaborator OTHER

  • SGS S.A.

    collaborator INDUSTRY

  • STRAGEN Services

    collaborator UNKNOWN

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Jean PELLETIER, MD · Head of Neurology Department, UMR CRMBM CNRS 6612, Timone University Hospital, Marseille, France

  • Ayman TOURBAH, MD · Professor of Neurology, Neurology Department & University of Reims

  • Gilles EDAN, MD · Professor of Clinical Neurology, Head of Neurology Department, Pontchaillou Hospital, Rennes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01808885 on ClinicalTrials.gov