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Biguanide
Metformin for Progressive Multiple Sclerosis
Phase < 1
Recruiting
Led By Kevin R Patel, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 30-65
Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by the 2017 McDonald Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between month 0 and month 12
Awards & highlights
Study Summary
This trial will test if metformin is a safe treatment for people with multiple sclerosis that is getting worse.
Who is the study for?
This trial is for people aged 30-65 with Progressive Multiple Sclerosis who have been stable on their current MS treatment for at least three months. They must not have had a clinical relapse or new lesions in the past year and should not be using metformin for other conditions, nor have kidney or liver issues, B12 deficiency, heart failure, alcohol abuse, metabolic acidosis, or plans to become pregnant.Check my eligibility
What is being tested?
The study is testing the safety of metformin (up to four 500 mg tablets daily) compared to a placebo in treating progressive multiple sclerosis. Participants will continue their usual MS treatments during the trial and either add metformin or a look-alike pill without active medication.See study design
What are the potential side effects?
Potential side effects of metformin include digestive upset like nausea and diarrhea, risk of vitamin B12 deficiency over time, and very rarely a serious condition called lactic acidosis where too much acid builds up in the blood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30 and 65 years old.
Select...
My condition is diagnosed as progressive multiple sclerosis according to the 2017 criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between month 0 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between month 0 and month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients with adverse events between baseline and conclusion (month 0 and month 12)
number of patients with laboratory abnormalities between baseline and conclusion (month 0 and month 12)
number of patients with new T2 lesions on MRI from baseline to conclusion (month 0 and month 12)
Secondary outcome measures
a reduction in localized cortical thinning on brain MRI between baseline and conclusion (month 0 and month 12)
a reduction in thalamic atrophy on brain MRI between baseline and conclusion (month 0 and month 12)
Other outcome measures
decrease in number of phase rimmed lesions between baseline and conclusion (month 0 and month 12)
decrease in plasma neurofilament light chain levels between baseline and conclusion (month 0 and month 12)
improvement in CVLT-II score between baseline and conclusion (month 0 and month 12)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Metformin TreatmentExperimental Treatment1 Intervention
Metformin 500 mg tablets up to 2,000 mg (4 tablets) a day divided into two doses. Patients will start on 500 mg Qday and a titration to maximum dose will be attempted during the first 30 day period of the study.
Group II: Placebo TreatmentPlacebo Group1 Intervention
Placebo tablets identical to metformin 500 mg tablets divided into two doses. Patients will be started on 1 tablet a day and a titration to maximum dose (4 tablets) will be attempted during the first 30 day period of the study.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,224 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
305 Patients Enrolled for Multiple Sclerosis
Kevin R Patel, MDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 30 and 65 years old.I plan to change my current treatment for my condition.My kidney function is reduced.I am not pregnant, planning to become pregnant, or breastfeeding during the trial.I have had a bad reaction to metformin before.My condition worsened in the last year.I had a bad reaction to metformin.I haven't changed my disease treatment in the last 3 months.I have signed the informed consent form.I am not taking any medications that interact with metformin.I have used glucocorticoids in the last 6 months, not just as premedication.I am currently taking metformin for a condition other than diabetes.My liver tests are higher than normal.My condition is diagnosed as progressive multiple sclerosis according to the 2017 criteria.I have been diagnosed with congestive heart failure.I plan to continue my current MS treatment throughout the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Treatment
- Group 2: Metformin Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the study's protocol accept minors for participation?
"Eligibility for this research study is limited to people aged between 30 and 65."
Answered by AI
What is the total number of participants for this research endeavor?
"Affirmative, according to the information published on clinicaltrials.gov, this medical study is currently looking for volunteers. Since April 26th 2022 when it was first posted and until May 2nd 2022 when its data were last updated, 44 participants need to be found at a single research site."
Answered by AI
Are there any opportunities for volunteers to join this experiment?
"Yes, according to clinicaltrials.gov this research endeavor is currently looking for individuals to join the study – it was first posted on April 26th 2022 and most recently updated May 2nd of the same year. 44 participants are expected at a single site."
Answered by AI
Does my candidacy qualify me to take part in this experiment?
"44 participants, aged between 30 and 65 years old with a diagnosis of either Primary Progressive Multiple sclerosis or Secondary Progressive Multiple Sclerosis according to the McDonald Criteria (2017), are sought for this trial. Additionally, each individual must consent to partake in the study and maintain their current MS-specific treatment protocol throughout its duration."
Answered by AI
Who else is applying?
What site did they apply to?
University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
No improvement with current and past meds.
PatientReceived 1 prior treatment
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