“CCMR2 is still open for new recruits” Alasdair Coles, Feb 2023

A trial of a possible remyelinating treatment in multiple sclerosis

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.

Metformin and clemastine, two drugs that are already licenced for diabetes and hay
fever 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 multiple sclerosis, which could potentially reverse or alleviate symptoms. The
purpose of this research is therefore to assess whether metformin and clemastine
really can promote remyelination in people.

Participants in the trial take several capsules twice daily for 6 months. There is a 50%
chance (much like flipping a coin) that these will contain metformin and clemastine. 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 at the beginning of this six-month period
and again at the end.

The trial is being conducted in Cambridge. Participants will need to attend fairly
frequently: at least 7 visits over a 38-week period are required. Participants should
have relapsing-remitting multiple sclerosis, be aged between 25 and 50 years, able to
walk for 100m (with no more than one walking aid). They should also be stable and have been taking a disease-modifying
drug for their MS for at least one year (beta-interferon, Copaxone, Tecfidera, Gilenya, Mavenclad) or two years (Ocrelizumab, Ofatumumab, Tysabri, Alemtuzumab).

Alasdair Coles, February 2023

This trial has been approved by a Research Ethics Committee:
EudraCT No: 2020-000242-34 IRAS ID No: 270342