Multiple Sclerosis (MS) - Relapsing-remittingPhase 2NCT06812585
The Effect of Metformin As an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: a Pilot Study
A Phase 2 study testing Metformin (Cidophage®) in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by German University in Cairo at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting
- What is being tested?
- Metformin (Cidophage®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals between 18 and 50 years of age who met the 2017 McDonald criteria were recruited.
- Patients with RRMS and had an EDSS score below 7.0.
- Participants were required to have been on a stable IFNβ-1a regimen for at least six months before the commencement of the study.
Who cannot join
- Individuals taking metformin or other diabetes medications, pregnant, and breastfeeding females were excluded.
- Those with congestive heart failure, liver impairment, kidney dysfunction, or chronic respiratory conditions were not eligible to participate.
- Additionally, patients who had undergone corticosteroids before or within 4 weeks of the study's commencement were ineligible for participation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Nasser Institute for Research and Treatment
Cairo, Cairo Governorate, 1053
About this study
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.
- Being tested
- Metformin (Cidophage®), Usual Care
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin (Cidophage®)Drug
Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes.
Usual CareOther
Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Receives: Other: Usual Care |
| 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 ®). Receives: Drug: Metformin (Cidophage®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum levels of neurofilament light chain in both arms
Measured: After 6 months
Secondary outcomes (3)
Change in serum levels of nuclear factor kappa B in both arms
Measured: After 6 months
Degree of remyelination visualized by MRI, it depends on clinician's overview.
Measured: After 6 months
Degree of disability assessed by Expanded Disability Status Scale.
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Apr 2022
- Primary completion30 May 2023
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- German University in Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Youssef Elsayed, German University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812585
- Sponsor's protocol ID
- MET in sNFL and NFK-B
- Status last verified
- Apr 2022
- First submitted
- 2 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41483718
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin As an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: a Pilot Study
- ClinicalTrials.gov ID
- NCT06812585
- Acronym / sponsor ID
- MET in sNFL and NFK-B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- German University in CairoUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Usual CareActive Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) |
| Intervention group | Experimental | Drug: Metformin (Cidophage®)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 ®). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals between 18 and 50 years of age who met the 2017 McDonald criteria were recruited.
- Patients with RRMS and had an EDSS score below 7.0.
- Participants were required to have been on a stable IFNβ-1a regimen for at least six months before the commencement of the study.
Key exclusion criteria (3 listed)
- Individuals taking metformin or other diabetes medications, pregnant, and breastfeeding females were excluded.
- Those with congestive heart failure, liver impairment, kidney dysfunction, or chronic respiratory conditions were not eligible to participate.
- Additionally, patients who had undergone corticosteroids before or within 4 weeks of the study's commencement were ineligible for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin (Cidophage®)Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes. | Drug | Intervention group |
| Usual CareActive Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) | Other | Control group |
Primary outcome
Change in serum levels of neurofilament light chain in both arms
Time frame: After 6 months
3 secondary outcomes
Change in serum levels of nuclear factor kappa B in both arms
Time frame: After 6 months
Degree of remyelination visualized by MRI, it depends on clinician's overview.
Time frame: After 6 months
Degree of disability assessed by Expanded Disability Status Scale.
Time frame: After 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 41483718Abdelgaied 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin (Cidophage®) in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by German University in Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum levels of neurofilament light chain in both arms (time frame: After 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06812585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.