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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

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CCMR Two: A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial of the Ability of the Combination of Metformin and Clemastine to Promote Remyelination in People With Relapsing-remitting Multiple Sclerosis Already on Disease-modifying Therapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 25 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participant is willing and able to give written informed consent for participation in the trial; - Male or female, aged between 25 and 50 years (inclusive) at time of signing informed consent form (ICF); - Relapsing-remitting multiple sclerosis as per the McDonald 2017 criteria (Thompson et al.
, 2018), including an MRI brain satisfying the McDonald 2017 criteria;
  • - VEP P100 latency in at least one eye of ≥118 ms; - Kurtzke EDSS 0.0-6.0; - At the time of screening being treated with a stable dose for at least 6 months of a category 1 multiple sclerosis DMT or for at least 2 years with a category 2 DMT; - Able (in the Investigator's opinion) and willing to comply with all trial requirements.

Exclusion Criteria:

  • - Female participants who are pregnant, lactating or planning pregnancy during the course of the trial; - Female participants of child-bearing potential whom are unwilling or unable to use one highly effective method of contraception during the trial (as outlined in section 11.11).
For the purpose of this document, a woman is considered of childbearing potential, i.e. fertile, following menarche and until post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause;
  • - Male participants who are unwilling or unable to use contraception during and for 3 months after the trial; - Participants whom have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the screening assessment or is currently enrolled in an interventional investigational trial; - Retinal nerve layer thickness on spectral-domain optical coherence tomography (OCT) <70 μm in the qualifying eye; - A clinical episode of optic neuritis in the qualifying eye within the 2 years preceding screening; - Any unlicensed treatment of multiple sclerosis; - Any concomitant use of oxybutynin, monoamine oxidase inhibitors (MAOIs), hypnotics or high-dose opiates at screening; - Significant renal impairment (eGFR <60 mL/min/1.73 m2); - Screening liver function (alanine aminotransferase, ALT) value greater than 3 times the upper limit of normal; - Known hypersensitivity to metformin or clemastine (or other arylalkylamine antihistamines) or any of the excipients of these products; - People taking medication for Diabetes Mellitus at screening; - People with a diagnosis of epilepsy; - People with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; - Concurrent use of 4-aminopyridine or fampridine; - Known contraindication(s) to MRI scanning procedures; - History of prostatic hypertrophy; - History of major ophthalmologic disease or concomitant ophthalmologic disorders including glaucoma, macular degeneration, and severe myopia (>-7 Diopters); - History of stenosing peptic ulcer or pyloroduodenal ulceration; - History of significant cardiac conduction block or decompensated heart failure; - History of acute porphyria; - People with a history of alcohol or other recreational drug misuse within the 6 months preceding screening; - People unable to avoid alcohol drinks for the course of the trial; - Vitamin B12 deficiency as defined as B12 levels of < 150 pg/ml measured at screening; - Any other significant disease, disability or investigation result which, in the opinion of the Investigator, may either put the participant at risk, or may influence the result of the trial, or the participant's ability to participate in the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05131828
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cambridge University Hospitals NHS Foundation Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nick Cunniffe
Principal Investigator Affiliation Cambridge University Hospitals NHS Foundation Trust & University of Cambridge
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Arms & Interventions

Arms

Experimental: Research arm: metformin and clemastine

Placebo Comparator: Control arm: placebos for both metformin + clemastine

Interventions

Drug: - Metformin and clemastine in combination

Metformin hydrochloride 500 mg prolonged release (SR) tablet for oral administration. Clemastine hydrogen fumarate 1.34 mg tablet for oral administration.

Drug: - Placebo

Placebo tablets to match both metformin and clemastine tablets.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Addenbrooke's Hospital, Cambridge, United Kingdom

Status

Recruiting

Address

Addenbrooke's Hospital

Cambridge, ,

Site Contact

CCMR Trials Team

[email protected]

01223 216187

Nearest Location

Site Contact

CCMR Trials Team

[email protected]

01223 216187


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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