A trial to determine bexarotene's safety and tolerability and it's ability to promote brain repair in patients with multiple sclerosis.

Phase 1

• Conditions: Relapsing-remitting multiple sclerosis already on interferon-beta therapy; MedDRA version: 17.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-003145-99-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-19
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Informed consent
- Male or female aged between 30 and 50 years inclusive
- Relapsing remitting multiple sclerosis as per the McDonald 2010 criteria, including an MRI satisfying the radiological criteria
- At least five T2 lesions, attributable to MS, on baseline MRI brain scan
- Kurtzke EDSS 3.0-6.0
- At least one relapse in the two years prior to screening
- At the time of screening (and for at least the last 6 months) being treated with interferon-beta (any preparation)
- Able and willing to comply with all study requirements

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients who are:
- Pregnant, lactating or planning pregnancy during course of trial
- Female and male participants unwilling or unable to use two reliable non-hormonal methods of contraception during the course of the trial and for one month thereafter
- Taking gemfibrozil
- Taking disease-modifying therapy for multiple sclerosis, other than interferon-beta within the previous six months
- Significant renal or hepatic impairment (Grade III or worse)
- Known hypersensitivity to bexarotene or to any of the excipients of the product
- Unwillingness to take a product containing gelatin
- Known reaction to gadolinium (within the contrast agent used for MRI scans)
- History of pancreatitis
- Fasting triglycerides over 2.3 mmol/L or baseline dyslipidaemia requiring treatment
- Known hypervitaminosis A
- Uncontrolled thyroid disease
- Excessive alcohol consumption (>24units/week for men, >14 units/week for women)
- Uncontrolled diabetes mellitus
- Biliary tract disease
- Hereditary fructose intolerance
- Use of CYP3A4-substrates (ketoconazole, itraconazole, protease inhibitors, clarithromycin and erythromycin) or CYP3A4-inducers (rifampicin, phenytoin, dexamethasone or phenobarbital), unless patients are willing to stop these (and it is safe to do so)
- Any other significant disease, disability or investigation result which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to establish the safety and tolerability of bexarotene in the treatment of relapsing remitting multiple sclerosis.;Secondary Objective: The secondary objective is to assess the efficacy of bexarotene in promoting myelin repair (remyelination) in relapsing remitting multiple sclerosis.<br><br>Exploratory objectives seek to assess bexarotene's effect on:<br>-lesions of different ages and severities; <br>-optic nerve function (giving a functional measure of whether a damaged (demyelinated) optic nerve may have remyelinated after bexarotene); <br>-patients' level of disability; <br>-immune markers in patient's bloods during and after treatment.;Primary end point(s): The primary endpoint is adverse events and withdrawals atributable to taking bexarotene. ;Timepoint(s) of evaluation of this end point: At the end of the 6 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint is mean lesional Magnetisation Transfer Ratio (MTR) between month 0 and month 6 for lesions selected for each patient whose MTR lies below the within-patient median. ;Timepoint(s) of evaluation of this end point: After 6 months of treatment