Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients

March 17, 2023 updated by: Mohamed Youssef Elsayed, German University in Cairo
This study aims to evaluate the effect of Metformin as add- on therapy for improving the outcome in RRMS patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis (MS) is an autoimmune-mediated neurodegenerative disease of the central nervous system characterized by inflammatory demyelination with axonal transection. Worldwide, there are about 2.3 million MS patients. Women are twice as likely to have MS as men. MS typically presents in young adults (mean age of onset, 20-30 years) and can lead to physical disability, cognitive impairment, and decreased quality of life.

The four main types of multiple sclerosis are clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), and primary progressive MS (PPMS). This research focuses on RRMS as it is the most common type (80%- 85%).

Elevated level of Interleukins, and oxidative stress parameters are associated with MS pathology which exaggerated the myelin destruction, axonal degradation, and inflammatory cascade.

Metformin has a global safety record, is well-tolerated by the majority of patients and is used by roughly 125 million people worldwide, so a lot of studies inside and outside Egypt investigates their potential effect in different disorders as neurodegenerative diseases and cancer. Despite the prevalence of animal studies which explored Metformin neuroprotective effects by decreasing T- helper cells (Th 1 and Th 17) and improving Oligodendrocyte progenitor cell responsiveness to induce remyelination, clinical trials are still insufficient which motivate us to investigate the promising effect of Metformin as add-on treatment in RRMS patients

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Nasser Institute for Research and Treatment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 50 years at time of signing informed consent form.
  • Relapsing- remitting multiple sclerosis as per the McDonald 2017 criteria, including an MRI brain satisfying the 2017 radiological criteria.
  • Full-field visual evoked potential (VEP) P100 latency in at least one eye of ≥118 ms.
  • Kurtzke EDSS step 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.

Exclusion Criteria:

  • People taking medication for Diabetes Mellitus at screening.
  • Female participants who are pregnant, lactating, planning pregnancy, or unwilling to use reliable contraception during the trial.
  • Significant liver impairment; alanine aminotransferase > 3 times the upper limit of normal.
  • People suffering from congestive heart failure, chronic lung disease with hypoxia, and severe anemia.
  • Patients with compromised renal function ((eGFR <60 mL/min/1.73m2) or coexistent hypoxic conditions should not be given metformin.
  • Chronic or acute intake of large amounts of alcohol may potentiate the effect of metformin on lactate metabolism.
  • Patients had been prescribed oral, intravenous, and intramuscular corticosteroids for one month prior to study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin (Cidophage®) and Interferon Beta 1 a (Rebiff ® 44mcg or Avonex ®)
Metformin 1000 mg (Cidophage® 1000 mg tablets, CID, Giza, Egypt) tablet twice daily for 6 months as add on therapy with Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®).
Drug: MetFORMIN 1000 Mg Oral Tablet
Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes.
Other Names:
  • Cidophage ®1000 mg tablets, CID, Giza, Egypt) tablet and Rebiff ® 44mcg or Avonex®
Drug: Interferon beta-1a
Disease Modifying Therapies (DMTs)
Other Names:
  • Rebiff ® 44mcg or Avonex®
Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®)
Drug: Interferon beta-1a
Disease Modifying Therapies (DMTs)
Other Names:
  • Rebiff ® 44mcg or Avonex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IL17 in both arms as measured by ELISA.
Time Frame: After 6 months
Anti-inflammatory marker
After 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Quality of Life deterioration in both arms measured by MSQOL-54.
Time Frame: After 6 months
Assessment of quality of life for patients, The highest and lowest values refer to the satisfaction degree of patients
After 6 months
Change in IL22 in both arms as measured by ELISA.
Time Frame: After 6 months
Anti-inflammatory marker
After 6 months
Malondialdehyde in both arms as measured by Colorimetric tests.
Time Frame: After 6 months
Anti-oxidant marker
After 6 months
Degree of remyelination visualized by MRI, it depends on clinician's overview.
Time Frame: After 6 months
Determination of T2 lesions
After 6 months
Degree of disability assessed by Expanded Disability Status Scale.
Time Frame: After 6 months
Determination disability level (0 - 6), The lowest value means that it is best outcome and the highest value is the worst outcome.
After 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German University in Cairo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Anticipated)

March 28, 2023

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSMet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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