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Metformin for ALS
Study Summary
This trial is assessing the safety and tolerability of Metformin in people with C9orf72 amyotrophic lateral sclerosis. The goal is to see if Metformin is safe and reduces the amount of RAN proteins produced by the C9orf72 mutation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT02002221Trial Design
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- I haven't taken any experimental drugs recently.I am a woman who can have children and will take a pregnancy test before my swallow study exams.I am not taking any medications that can harm my liver.I am willing to sign the consent form and HIPAA authorization.I understand what participating in this study involves.You have a pacemaker, neurostimulator, or metal objects in your body that could be harmed during the MRI part of the study.I do not have severe liver, kidney, or other medical conditions that a doctor would find concerning.I likely have ALS/FTD linked to the C9orf72 gene.I am currently taking Metformin or have taken it in the past.I am willing and able to sign the informed consent.My kidney function is significantly reduced, with an eGFR below 30.My liver is not functioning properly, shown by high enzyme levels or bilirubin.I have been diagnosed with ALS according to specific criteria.I can eat and drink normally without any assistance.I haven't had active cancer in the last 2 years, except for treated skin cancer.I am not pregnant, trying to conceive, or breastfeeding.My lab tests show I don't have the C9ORF72 gene mutation.You have difficulty eating or drinking.You have abnormal test results that the doctor thinks are important.I am not allergic to barium sulfate or Metformin.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- Group 1: C9orf72 positive ALS
Frequently Asked Questions
Does this study admit participants younger than fifty-five years of age?
"This study is seeking out individuals aged 18 and over, up to 80 years of age."
What pharmacological treatment is usually prescribed for C9orf72 positive ALS?
"C9orf72 positive ALS is regularly prescribed to treat exercise-induced afflictions. Additionally, this medication has been known to be beneficial in alleviating the symptoms of type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."
What other investigations have focused on C9orf72 positive amyotrophic lateral sclerosis?
"Presently, there are 170 clinical trials examining C9orf72 positive ALS. Out of those active studies, 43 have entered Phase 3. Pittsburgh is the primary base for this research, however 1903 other sites host similar experiments."
What is the magnitude of enrollment in this medical experiment?
"Affirmative. According to the data listed on clinicaltrials.gov, this medical investigation is currently admitting participants; it was first posted in January 10th 2020 and updated lastly on September 15th 2022. This trial has room for 58 individuals from a single site."
What safety concerns should be taken into consideration for individuals with C9orf72 positive ALS?
"The safety of C9orf72 positive ALS is rated at a 2 due to the lack of efficacy data, yet there have been studies that showcase its potential for being safe."
Are there any remaining positions available to participate in this trial?
"According to details found on clinicaltrials.gov, the study is now recruiting patients after being first published in January 10th 2020 and recently updated in September 15th 2022."
What are the eligibility requirements for those wishing to join this experiment?
"This research is recruiting 58 adults, aged between 18 and 80 who suffer from semantic dementia. In order to be eligible for the trial, participants need to have taken Metformin either currently or in the past; they must also remain available until completion of the study, capable of ingesting solids and liquids orally at a rate equivalent to 4 points on the Functional Oral Intake Scale (FOIS), able to comprehend what's being asked of them by investigators, as well as willing and physically fit enough take part in all activities associated with this clinical trial."
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