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

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ClinicalTrials.gov Identifier: NCT01808885
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : November 22, 2016
Sponsor:
Collaborators:
Hôpital de la Timone
SGS S.A.
STRAGEN Services
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: olesoxime (TRO19622) Drug: placebo Phase 1

Detailed Description:

The primary objective of this study is to characterize the general safety and tolerability of olesoxime (495 mg, od), compared to placebo when administered in combination with Interferon beta over a 24-week treatment period in patients with stable Relapsing Remitting Multiple Sclerosis.

The secondary objective of this study is to evaluate the feasibility of multicenter protocols for measurement of neurodegeneration and remyelination by MRI as well as the plasma exposure to olesoxime (495 mg, od).

MRI will be performed to all patients to assess effects of olesoxime on brain inflammation as well as to assess measures of brain atrophy, neuronal damage and myelination status at Baseline, 12 weeks and 24 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.
Study Start Date : April 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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: 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).

Other Name: TRO19622 (olesoxime)

Placebo Comparator: placebo
placebo (3 soft capsules, od) will be administered orally for 6 months
Drug: placebo
placebo capsule shells with identical appearance as the active compound TRO19622




Primary Outcome Measures :
  1. Safety criteria [ Time Frame: The primary endpoint of this study will be the cumulative incidence of AE/SAE assessed by ongoing monitoring at week 24 (day 168) ]
    Cumulative incidence of adverse events/serious adverse events (i.e. total number per patient) as assessed by ongoing monitoring.


Secondary Outcome Measures :
  1. MRI Parameters [ Time Frame: Baseline (Visit 0), Week 12 (Visit 2) and Week 24 (Visit 3/Final Visit) ]
    1. Number of Gadolinium-enhancing lesions on T1-weighted images
    2. Number of new or enlarged lesions on T2-weighted images


Other Outcome Measures:
  1. Exploratory MRI Parameters [ Time Frame: Baseline (Visit 0), Week 12 (Visit 2) and Week 24 (Visit 3/Final Visit) ]

    Exploratory Endpoints:

    The following parameters will be assessed in terms of feasibility and reproducibility in a multicenter setting:

    3. Whole brain atrophy volume assessed by 3D-T1-weighted images. 4. Demyelination and remyelination processes assessed by Diffusion Tensor Imaging.

    5. Remyelination processes assessed by Magnetization Transfer Ratio. 6. Neuroaxonal damage assessed by sodium 23 imaging in one center.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years old
  • Diagnosed with Relapsing Remitting Multiple Sclerosis. Patients must be stable defined as free from relapsing episode for at least 6 months prior to Baseline
  • Patients must be treated with Interferon beta for at least one year
  • Patients must have an Expanded Disability Status Scale (EDSS) score ≤ 5
  • Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception for at least 3 months prior to Baseline and during the study. In addition, female patients must not be lactating
  • Patients must be able to understand and comply with study requirements
  • Patients must provide a written, dated and signed informed consent prior to any study procedure

Exclusion Criteria:

  • Any relapse of multiple sclerosis within the past 6 months prior to Screening Visit/Visit -1
  • Any change in Interferon treatment within the past year prior to Screening Visit (Visit -1)
  • Expected use of another disease modifying therapy from Screening Visit/Visit -1 to Visit 3/Final Visit
  • Patients unable to undergo MRI scan
  • Current or expected use of a medication that could interfere with olesoxime pharmacology (e.g. tamoxifen)
  • Current or expected use of lipid lowering agents (ezetimibe, bile salt chelators, fibrates, phytosterols) other than statins
  • Known hypersensitivity to olesoxime or any of its components
  • History of alcohol or drug abuse within the last 6 months, or addiction within the last 2 years prior to Baseline Visit
  • Positive urinary pregnancy test at Baseline Visit
  • History of hepatitis B/C or HIV positive serology
  • Hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> 3 × ULN) at Baseline Visit
  • History of renal impairment defined by a serum creatinine value > 176 μmol/L (2.0 mg/dL) at Baseline Visit
  • Abnormal and clinically significant ECG at Screening Visit/Visit -1 as assessed by a cardiologist
  • Current or expected use of oral or intramuscular corticosteroids within 3 months prior to the Screening Visit. Only stable dose regimens of inhaled and topical corticosteroids are allowed during the study
  • History of any clinically relevant gastrointestinal (GI), respiratory, psychiatric, neurological, kidney, liver, cardiac diseases, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives or put the patient's safety at risk, as judged by the Investigator
  • Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than Multiple Sclerosis (MS)
  • History of malignancy of any organ, treated or non-treated within the past 5 years
  • Current participation or participation within 30 days prior to study entry, in another investigational drug or device study, or previous enrolment in the present study
  • Any direct involvement with the study conduct at site or any family link with study site staff
  • Pregnant, parturient or lactating women, as per Public Health Code (CSP)(Article L-1121-5)
  • Persons deprived of their liberty by a judicial or administrative decision, and those admitted to a health or social facility, as per CSP (Article L-1121-6)
  • Persons covered by a measure of legal protection or unable to provide a written, dated and signed informed consent, as per CSP(Article L-1121-8)
  • Patient without Social Security Insurance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808885


Locations
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France
Timone University Hospital, Neurology Department, UMR CRMBM CNRS 6612
Marseille, France, 13385
CHU Reims, Maison Blanche Hospital, Neurology Department & University of Reims
Reims, France, 51092
CHU Pontchaillou, Neurology Department
Rennes, France, 35033
Sponsors and Collaborators
Hoffmann-La Roche
Hôpital de la Timone
SGS S.A.
STRAGEN Services
Investigators
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Principal Investigator: Jean PELLETIER, MD Head of Neurology Department, UMR CRMBM CNRS 6612, Timone University Hospital, Marseille, France
Principal Investigator: Ayman TOURBAH, MD Professor of Neurology, Neurology Department & University of Reims
Principal Investigator: Gilles EDAN, MD Professor of Clinical Neurology, Head of Neurology Department, Pontchaillou Hospital, Rennes, France

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01808885     History of Changes
Other Study ID Numbers: WP29866
2012-005186-12 ( EudraCT Number )
TRO19622CLEQ1585-1 ( Other Identifier: trophos id )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Hoffmann-La Roche:
safety
multiple sclerosis
olesoxime
double-blind
randomized

Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs