CCMR One
Research type
Research Study
Full title
A randomised placebo-controlled study of the safety and tolerability of a retinoid-X receptor agonist's ability to promote remyelination in people with relapsing-remitting multiple sclerosis already on interferon-beta therapy: a phase 2a trial
IRAS ID
160672
Contact name
Alasdair Coles
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2014-003145-99
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Relapsing remitting multiple sclerosis is an autoimmune disease of the central nervous system where the insulation surrounding nerves (the myelin sheath) becomes damaged by inflammation. Initially, patients largely recover from episodes due to myelin repair (remyelination). Later, remyelination fails and the nerve axons themselves degenerate (neurodegenaration) leading to the secondary progressive phase of the disease characterised by gradual accumulation of disability. This secondary progressive phase brings most morbidity with increasing frequency of unemployment, depression, marital breakup and reduced life expectancy.
Early treatment with powerful immunotherapies has proved successful in preventing the secondary progressive phase of multiple sclerosis. However, not all patients will receive or tolerate a potent immunotherapy early in the course of their disease; thus the greatest unmet need in the current treatment of multiple sclerosis is prevention or treatment of the secondary progressive phase. In this trial we propose testing such a treatment using a strategy to promote remyelination in people with relapsing remitting multiple sclerosis who have residual disability from previous relapses. We will use a drug, bexarotene, which is currently used for the treatment of cutaneous T-cell lymphoma but has not been used in multiple sclerosis or any other autoimmune disease. Bexarotene has the ability to bind and activate retinoid X receptors which has been shown to initiate the process of remyelination in rats. The use of bexarotene will test the role of retinoid X receptor agonists in human remyelination.
There is evidence suggesting that remyelination is normally effective and rapid in young animals but declines in efficiency with age; we will therefore recruit slightly older patients (aged 30 to 50 years) for this trial to optimise the chances of detecting a treatment effect.REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0108
Date of REC Opinion
19 Mar 2015
REC opinion
Further Information Favourable Opinion