A Phase 2 interventional study of Metformin and clemastine in combination and Placebo in Multiple Sclerosis, sponsored by Cambridge University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Phase 2, Interventional, and Treatment
The greatest unmet need for people with multiple sclerosis is an effective therapy for the progressive phase. Current treatments suppress the damage caused by the immune system but there is only a limited window in which these can work. Consequently, much of the research community is turning its attention to the process of repair, called remyelination, in which the lining of nerve cells is reformed. This protects nerves from dying and therefore can delay, prevent, or even reverse, disability progression.
It has previously been shown that stem cells are already present in the brain that can carry out this process. Clemastine, an anti-histamine drug, can instruct them to become active and has already shown a beneficial effect in a phase 2 trial. Now, more recent experiments have shown that changes take place within these stem cells as they age, which prevents them responding to drugs like clemastine, but that this can be reversed by treatment with metformin, a commonly used anti-diabetes drug.
Our goal is to establish whether the combination of metformin and clemastine can promote remyelination in people with MS. We will focus on people with relapsing MS as they will have a greater proportion of nerves healthy enough to allow remyelination to take place, which will maximise the chance of detecting an effect with a smaller sample size.
Participants will also continue treatment with a current disease-modifying MS treatment, to reduce the chance of developing new areas of damage, allowing the trial to focus on the repair process. The treatment duration will be 24 weeks, but given the established safety of the proposed medications, we are able to limit the number of visits to the trial centre to ensure participation is not overly burdensome.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 70 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Metformin and clemastine in combination
Drug: Placebo
Metformin hydrochloride 500 mg prolonged release (SR) tablet for oral administration. Clemastine hydrogen fumarate 1.34 mg tablet for oral administration.
Placebo tablets to match both metformin and clemastine tablets.
the change in the P100 latency of the full-field visual evoked potential (VEP) between baseline and week 26 for each affected eye of participants
Time frame: Baseline to week 26
The change in MF-VEP latency, between baseline and week 26, for those eyes with delayed latency at baseline
Time frame: Baseline to week 26
The change in lesional MTR, between baseline and week 26, for the lesions stratified by location
Time frame: Baseline to week 26
The change in lesional MTR between baseline and week 26, for the lesions stratified by tissue-specific cohort baseline lesional MTR values
Time frame: Baseline to week 26
Adverse events and withdrawals attributable to metformin and/or clemastine
Time frame: Baseline to week 28
The change, between baseline and week 26, in the N75 and N145 latencies of the full-field VEP
Time frame: Baseline to week 26
The change in full field VEP amplitude, between baseline and week 26, for those eyes with delayed latency at baseline
Time frame: Baseline to week 26
The change in MF-VEP amplitude, between baseline and week 26, for those eyes with delayed latency at baseline
Time frame: Baseline to week 26
The change in the number of letters read (and the corresponding LogMAR score) on the Sloan 100%, 2.5% and 1.25% acuity charts, between baseline and week 28
Time frame: Baseline to week 28
The change in colour vision between baseline and week 28
Time frame: Baseline to week 28
The change in visual fields between baseline and week 28
Time frame: Baseline to week 28
The change in saccadic latency parameters in the step, antisaccade and Wheeless tasks between screening and week 28
Time frame: Screening to week 28
The change in retinal nerve fibre layer thickness between screening and week 28
Time frame: Screening to week 28
The change in MTR of lesional subcomponents and lesional voxels, stratified by location, between baseline and week 26
Time frame: Baseline to week 26
The change in lesional MTR between baseline and week 26, for different lesion types
Time frame: Baseline to week 26
The change in MRI T2 lesion load between baseline and week 26
Time frame: Baseline to week 26
The change between baseline and week 26 measured by different MRI biomarkers of remyelination
Time frame: Baseline to week 26
The change in EDSS between screening and week 26
Time frame: Screening to week 26
Plan to share: No
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Cambridge University Hospitals NHS Foundation Trust