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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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbetween 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.
Eligible Conditions
- Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You must be between 30 and 65 years old.
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You have a specific type of multiple sclerosis that is defined by certain medical guidelines from 2017.
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You plan to keep taking your current medication for multiple sclerosis during the trial.
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
1,493 Previous Clinical Trials
10,284,507 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:- You have experienced a return of your medical condition within the past year.You have had a new type 2 lesion or a lesion that lights up with gadolinium dye in the past 12 months.You have taken glucocorticoid medications for reasons other than preparing for a specific type of treatment in the past six months.You have changed your disease treatment in the last three months.You are planning to switch your current medication for your condition.You cannot have an MRI or are unable to handle an MRI.You are taking metformin for reasons other than the intended purpose of this study.Your kidneys are not working well (GFR < 60).Your liver function tests show that your liver is not working properly.You have low levels of vitamin B12.You had a bad reaction to metformin before.You have congestive heart failure.You have a history of drinking too much alcohol.You have a condition called metabolic acidosis.You are taking other medications that may interact with metformin.You had a bad reaction to metformin before.You must be between 30 and 65 years old.You have a specific type of multiple sclerosis that is defined by certain medical guidelines from 2017.You plan to keep taking your current medication for multiple sclerosis during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin Treatment
- Group 2: Placebo 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
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