CCMR Three
Research type
Research Study
Full title
Cambridge Centre for Myelin Repair Trial Three: a phase 2b, randomised, single-site, double-blind, placebo-controlled trial of the combination of six months of low-dose bexarotene and tamoxifen to promote remyelination in adults with relapse remitting multiple sclerosis stable on disease-modifying therapy
IRAS ID
1008610
Contact name
Alasdair Coles
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Research summary
Nerves in the brain and spinal cord are normally surrounded by a protective layer of a substance called myelin (similar to the plastic insulation of an electric cable). In multiple sclerosis (MS), the immune system attacks the myelin, leaving nerve fibres (similar to the metal wire in the cable) unprotected. This causes nerves to malfunction, resulting in multiple sclerosis symptoms. Over time, unprotected nerve fibres die, leading to the progressive phase of MS. To avoid this happening, we are trying to promote remyelination – the process by which myelin is regenerated.
Bexarotene and tamoxifen, two drugs that are already licenced for lymphoma (a type of cancer) and breast cancer respectively, have recently been found to work together to promote remyelination in animals. We believe that this combination may also promote remyelination in people with MS, which could potentially reverse or alleviate symptoms. The purpose of this research is therefore to assess whether bexarotene and tamoxifen really can promote remyelination in people.
Participants in the trial take four capsules daily for 6 months. There is a 50% chance (much like flipping a coin) that these will contain bexarotene and tamoxifen. The other half of participants will receive “dummy drugs” called placebos. Neither the participant, nor the trial doctor, knows which treatment they are taking. Remyelination is assessed by an eye test and an MRI scan before starting the treatment and repeated twice after completing the treatment.
The trial is being conducted in Cambridge. Participants will need to attend fairly frequently: at least 14 visits (8 may be conducted remotely) over a 58-week period are required. Participants should have relapsing-remitting MS, be aged between 18 and 50 years, able to walk for 100m (with no more than one walking aid) , and should be taking a disease-modifying drug for their MS (beta-interferon, Copaxone, Tecfidera, Gilenya, Tysabri etc.).
REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0897
Date of REC Opinion
12 Dec 2023
REC opinion
Further Information Favourable Opinion