Multiple SclerosisPhase 2NCT05298670
Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients
A Phase 2 study testing MetFORMIN 1000 Mg Oral Tablet and Interferon beta-1a in people with Multiple Sclerosis, run by German University in Cairo at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of Metformin as add- on therapy for improving the outcome in RRMS patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MetFORMIN 1000 Mg Oral Tablet and Interferon beta-1a
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 28 Mar 2023
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nasser Institute for Research and Treatment
Cairo
Mohamed Hamed, PhD
About this study
This study aims to evaluate the effect of Metformin as add- on therapy for improving the outcome in RRMS patients.
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- MetFORMIN 1000 Mg Oral Tablet, Interferon beta-1a
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetFORMIN 1000 Mg Oral TabletDrug
Also called Cidophage ®1000 mg tablets, CID, Giza, Egypt) tablet and Rebiff ® 44mcg or Avonex®
Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes.
Interferon beta-1aDrug
Also called Rebiff ® 44mcg or Avonex®
Disease Modifying Therapies (DMTs)
| Study group | Role | What they receive |
|---|---|---|
| Metformin (Cidophage®) and Interferon Beta 1 a (Rebiff ® 44mcg or Avonex ®) | Experimental | 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 1000 Mg Oral Tablet; Drug: Interferon beta-1a |
| Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) | Active comparator | Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Receives: Drug: Interferon beta-1a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IL17 in both arms as measured by ELISA.
Anti-inflammatory marker
Measured: After 6 months
Secondary outcomes (5)
Percentage of Quality of Life deterioration in both arms measured by MSQOL-54.
Assessment of quality of life for patients, The highest and lowest values refer to the satisfaction degree of patients
Measured: After 6 months
Change in IL22 in both arms as measured by ELISA.
Anti-inflammatory marker
Measured: After 6 months
Malondialdehyde in both arms as measured by Colorimetric tests.
Anti-oxidant marker
Measured: After 6 months
Degree of remyelination visualized by MRI, it depends on clinician's overview.
Determination of T2 lesions
Measured: After 6 months
Degree of disability assessed by Expanded Disability Status Scale.
Determination disability level (0 - 6), The lowest value means that it is best outcome and the highest value is the worst outcome.
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 posted28 Mar 2022
- Study start1 Feb 2022
- Primary completion28 Feb 2023
- Study completion28 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- 80 participants (estimated)
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
- NCT05298670
- Sponsor's protocol ID
- MSMet
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loma I, Heyman R. Multiple sclerosis: pathogenesis and treatment. Curr Neuropharmacol. 2011 Sep;9(3):409-16. doi: 10.2174/157015911796557911.
PubMed 22379455Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, Thompson AJ. Atlas of Multiple Sclerosis 2013: A growing global problem with widespread inequity. Neurology. 2014 Sep 9;83(11):1022-4. doi: 10.1212/WNL.0000000000000768. No abstract available.
PubMed 25200713Sormani MP, De Rossi N, Schiavetti I, Carmisciano L, Cordioli C, Moiola L, Radaelli M, Immovilli P, Capobianco M, Trojano M, Zaratin P, Tedeschi G, Comi G, Battaglia MA, Patti F, Salvetti M; Musc-19 Study Group. Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis. Ann Neurol. 2021 Apr;89(4):780-789. doi: 10.1002/ana.26028. Epub 2021 Feb 9.
PubMed 33480077Pegoretti V, Swanson KA, Bethea JR, Probert L, Eisel ULM, Fischer R. Inflammation and Oxidative Stress in Multiple Sclerosis: Consequences for Therapy Development. Oxid Med Cell Longev. 2020 May 12;2020:7191080. doi: 10.1155/2020/7191080. eCollection 2020.
PubMed 32454942Negrotto L, Farez MF, Correale J. Immunologic Effects of Metformin and Pioglitazone Treatment on Metabolic Syndrome and Multiple Sclerosis. JAMA Neurol. 2016 May 1;73(5):520-8. doi: 10.1001/jamaneurol.2015.4807.
PubMed 26953870Triggle CR, Ding H. Metformin is not just an antihyperglycaemic drug but also has protective effects on the vascular endothelium. Acta Physiol (Oxf). 2017 Jan;219(1):138-151. doi: 10.1111/apha.12644. Epub 2016 Jan 13.
PubMed 26680745Sportelli C, Urso D, Jenner P, Chaudhuri KR. Metformin as a Potential Neuroprotective Agent in Prodromal Parkinson's Disease-Viewpoint. Front Neurol. 2020 Jun 12;11:556. doi: 10.3389/fneur.2020.00556. eCollection 2020.
PubMed 32595595Demare S, Kothari A, Calcutt NA, Fernyhough P. Metformin as a potential therapeutic for neurological disease: mobilizing AMPK to repair the nervous system. Expert Rev Neurother. 2021 Jan;21(1):45-63. doi: 10.1080/14737175.2021.1847645. Epub 2020 Dec 4.
PubMed 33161784Shi Q, Liu S, Fonseca VA, Thethi TK, Shi L. Effect of metformin on neurodegenerative disease among elderly adult US veterans with type 2 diabetes mellitus. BMJ Open. 2019 Jul 30;9(7):e024954. doi: 10.1136/bmjopen-2018-024954.
PubMed 31366635Dowling RJ, Goodwin PJ, Stambolic V. Understanding the benefit of metformin use in cancer treatment. BMC Med. 2011 Apr 6;9:33. doi: 10.1186/1741-7015-9-33.
PubMed 21470407Brown JR, Chan DK, Shank JJ, Griffith KA, Fan H, Szulawski R, Yang K, Reynolds RK, Johnston C, McLean K, Uppal S, Liu JR, Cabrera L, Taylor SE, Orr BC, Modugno F, Mehta P, Bregenzer M, Mehta G, Shen H, Coffman LG, Buckanovich RJ. Phase II clinical trial of metformin as a cancer stem cell-targeting agent in ovarian cancer. JCI Insight. 2020 Jun 4;5(11):e133247. doi: 10.1172/jci.insight.133247.
PubMed 32369446Ayoub R, Ruddy RM, Cox E, Oyefiade A, Derkach D, Laughlin S, Ades-Aron B, Shirzadi Z, Fieremans E, MacIntosh BJ, de Medeiros CB, Skocic J, Bouffet E, Miller FD, Morshead CM, Mabbott DJ. Assessment of cognitive and neural recovery in survivors of pediatric brain tumors in a pilot clinical trial using metformin. Nat Med. 2020 Aug;26(8):1285-1294. doi: 10.1038/s41591-020-0985-2. Epub 2020 Jul 27.
PubMed 32719487El-Khayat SM, Abouegylah M, Abdallah D, Geweil AG, Elenbaby AM, Zahra OS. The effect of metformin when combined with neoadjuvant chemotherapy in breast cancer patients. Med Oncol. 2021 Nov 5;39(1):1. doi: 10.1007/s12032-021-01599-3.
PubMed 34739637El-Fatatry BM, Ibrahim OM, Hussien FZ, Mostafa TM. Role of metformin in oxaliplatin-induced peripheral neuropathy in patients with stage III colorectal cancer: randomized, controlled study. Int J Colorectal Dis. 2018 Dec;33(12):1675-1683. doi: 10.1007/s00384-018-3104-9. Epub 2018 Jun 21.
PubMed 29931409Neumann B, Baror R, Zhao C, Segel M, Dietmann S, Rawji KS, Foerster S, McClain CR, Chalut K, van Wijngaarden P, Franklin RJM. Metformin Restores CNS Remyelination Capacity by Rejuvenating Aged Stem Cells. Cell Stem Cell. 2019 Oct 3;25(4):473-485.e8. doi: 10.1016/j.stem.2019.08.015.
PubMed 31585093
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05298670
- Acronym / sponsor ID
- MSMet
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- German University in CairoUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Mar 2023 (estimated)
- First posted
- 28 Mar 2022 (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 study aims to evaluate the effect of Metformin as add- on therapy for improving the outcome in RRMS patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin (Cidophage®) and Interferon Beta 1 a (Rebiff ® 44mcg or Avonex ®) | Experimental | Drug: MetFORMIN 1000 Mg Oral Tablet, Drug: Interferon beta-1aMetformin 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 ®). |
| Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) | Active comparator | Drug: Interferon beta-1aInterferon 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 (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 1000 Mg Oral TabletAlso: Cidophage ®1000 mg tablets, CID, Giza, Egypt) tablet and Rebiff ® 44mcg or Avonex®Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes. | Drug | Metformin (Cidophage®) and Interferon Beta 1 a (Rebiff ® 44mcg or Avonex ®) |
| Interferon beta-1aAlso: Rebiff ® 44mcg or Avonex®Disease Modifying Therapies (DMTs) | Drug | Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®), Metformin (Cidophage®) and Interferon Beta 1 a (Rebiff ® 44mcg or Avonex ®) |
Primary outcome
Change in IL17 in both arms as measured by ELISA.
Time frame: After 6 months
Anti-inflammatory marker
5 secondary outcomes
Percentage of Quality of Life deterioration in both arms measured by MSQOL-54.
Time frame: After 6 months
Change in IL22 in both arms as measured by ELISA.
Time frame: After 6 months
Malondialdehyde in both arms as measured by Colorimetric tests.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Background: PubMed 22379455Loma I, Heyman R. Multiple sclerosis: pathogenesis and treatment. Curr Neuropharmacol. 2011 Sep;9(3):409-16. doi: 10.2174/157015911796557911.
- Background: PubMed 25200713Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, Thompson AJ. Atlas of Multiple Sclerosis 2013: A growing global problem with widespread inequity. Neurology. 2014 Sep 9;83(11):1022-4. doi: 10.1212/WNL.0000000000000768. No abstract available.
- Background: PubMed 33480077Sormani MP, De Rossi N, Schiavetti I, Carmisciano L, Cordioli C, Moiola L, Radaelli M, Immovilli P, Capobianco M, Trojano M, Zaratin P, Tedeschi G, Comi G, Battaglia MA, Patti F, Salvetti M; Musc-19 Study Group. Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis. Ann Neurol. 2021 Apr;89(4):780-789. doi: 10.1002/ana.26028. Epub 2021 Feb 9.
- Background: PubMed 32454942Pegoretti V, Swanson KA, Bethea JR, Probert L, Eisel ULM, Fischer R. Inflammation and Oxidative Stress in Multiple Sclerosis: Consequences for Therapy Development. Oxid Med Cell Longev. 2020 May 12;2020:7191080. doi: 10.1155/2020/7191080. eCollection 2020.
- Background: PubMed 26953870Negrotto L, Farez MF, Correale J. Immunologic Effects of Metformin and Pioglitazone Treatment on Metabolic Syndrome and Multiple Sclerosis. JAMA Neurol. 2016 May 1;73(5):520-8. doi: 10.1001/jamaneurol.2015.4807.
- Background: PubMed 26680745Triggle CR, Ding H. Metformin is not just an antihyperglycaemic drug but also has protective effects on the vascular endothelium. Acta Physiol (Oxf). 2017 Jan;219(1):138-151. doi: 10.1111/apha.12644. Epub 2016 Jan 13.
- Background: PubMed 32595595Sportelli C, Urso D, Jenner P, Chaudhuri KR. Metformin as a Potential Neuroprotective Agent in Prodromal Parkinson's Disease-Viewpoint. Front Neurol. 2020 Jun 12;11:556. doi: 10.3389/fneur.2020.00556. eCollection 2020.
- Background: PubMed 33161784Demare S, Kothari A, Calcutt NA, Fernyhough P. Metformin as a potential therapeutic for neurological disease: mobilizing AMPK to repair the nervous system. Expert Rev Neurother. 2021 Jan;21(1):45-63. doi: 10.1080/14737175.2021.1847645. Epub 2020 Dec 4.
- Background: PubMed 31366635Shi Q, Liu S, Fonseca VA, Thethi TK, Shi L. Effect of metformin on neurodegenerative disease among elderly adult US veterans with type 2 diabetes mellitus. BMJ Open. 2019 Jul 30;9(7):e024954. doi: 10.1136/bmjopen-2018-024954.
- Background: PubMed 21470407Dowling RJ, Goodwin PJ, Stambolic V. Understanding the benefit of metformin use in cancer treatment. BMC Med. 2011 Apr 6;9:33. doi: 10.1186/1741-7015-9-33.
- Background: PubMed 32369446Brown JR, Chan DK, Shank JJ, Griffith KA, Fan H, Szulawski R, Yang K, Reynolds RK, Johnston C, McLean K, Uppal S, Liu JR, Cabrera L, Taylor SE, Orr BC, Modugno F, Mehta P, Bregenzer M, Mehta G, Shen H, Coffman LG, Buckanovich RJ. Phase II clinical trial of metformin as a cancer stem cell-targeting agent in ovarian cancer. JCI Insight. 2020 Jun 4;5(11):e133247. doi: 10.1172/jci.insight.133247.
- Background: PubMed 32719487Ayoub R, Ruddy RM, Cox E, Oyefiade A, Derkach D, Laughlin S, Ades-Aron B, Shirzadi Z, Fieremans E, MacIntosh BJ, de Medeiros CB, Skocic J, Bouffet E, Miller FD, Morshead CM, Mabbott DJ. Assessment of cognitive and neural recovery in survivors of pediatric brain tumors in a pilot clinical trial using metformin. Nat Med. 2020 Aug;26(8):1285-1294. doi: 10.1038/s41591-020-0985-2. Epub 2020 Jul 27.
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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.
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 1000 Mg Oral Tablet and Interferon beta-1a in people with Multiple Sclerosis, 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Elsayed, master (+2001091282830, mohamed.yosefelsayed@student.guc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IL17 in both arms as measured by ELISA. (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 NCT05298670, which also lists 19 linked publications.
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 20 Mar 2023.