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This pilot study aims to investigate the tolerability and feasibility of using metformin as an adjuvant treatment for RRMS. Also, it aims to evaluate the preliminary evidence of its efficacy by analyzing outcomes related to immunology, clinical manifestations, and radiological findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) |
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| Intervention group | Experimental | 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 ®). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin (Cidophage®) | Drug | Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in serum levels of neurofilament light chain in both arms | After 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum levels of nuclear factor kappa B in both arms | After 6 months | |
| Degree of remyelination visualized by MRI, it depends on clinician's overview. | After 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nasser Institute for Research and Treatment | Cairo | Cairo Governorate | 1053 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41483718 | Derived | Abdelgaied MY, Abdelgawad O, Rashad MH, Solayman MH, El-Tayebi HM. Efficacy and tolerability of metformin as an adjuvant therapy in patients with relapse-remitting multiple sclerosis receiving interferon Beta 1a: A randomized pilot trial. J Neuroimmunol. 2026 Mar;412:578852. doi: 10.1016/j.jneuroim.2025.578852. Epub 2025 Dec 31. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Usual Care | Other | Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) |
|
| Degree of disability assessed by Expanded Disability Status Scale. |
| After 6 months |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |