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Anti-diabetic drug

Metformin for Fragile X Syndrome (Met Trial)

Phase 2 & 3

Recruiting

Led By Randi J Hagerman, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8, end of treatment/week 16

Awards & highlights

Met Trial Summary

This trial will study the effects of the drug metformin on people with fragile X syndrome. It will test if the drug is safe and effective in treating language deficits, behavior problems, and obesity/excessive appetite in these individuals.

Who is the study for?

This trial is for individuals aged 6-25 with Fragile X syndrome, able to speak in phrases and have an IQ ≤ 79. They must be willing to attend regular clinic visits, not have used metformin recently, and maintain a stable medication regimen. Women of childbearing age should use birth control.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of metformin versus placebo on language deficits, behavior issues, and obesity/appetite in those with Fragile X syndrome over three visits within four months using a double-blind randomized design.See study design

What are the potential side effects?

While not specified here, common side effects of metformin may include stomach upset or discomfort, diarrhea, gas, headache, heartburn; however individual experiences can vary.

Met Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8, end of treatment/week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8, end of treatment/week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8, end of treatment/week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in the Expressive Language Sampling (ELS) mean Number of Different Words (NDW) score

Secondary outcome measures

Change from baseline in the Anxiety Depression and Mood Screen (ADAMS) overall score

Change from baseline in the Child Sleep Habits Questionnaire (CSHQ) overall score

Fragile X Syndrome

+5 more

Met Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Metformin MedicationActive Control1 Intervention

The active metformin medication will be dosed in a weight-dependent manner. Liquid metformin (100mg/cc) will be provided to any participants unable to swallow the metformin capsules. For participants under 50kg at baseline, the initial dose will be 250mg once per day, and if this dose is well tolerated, they will increase each week by 250mg until a maximum dose of 1000mg daily is reached. For participants at and above 50kg at baseline, the initial dose will be 500mg once per day, and if this dose is well tolerated, they will increase each week by 500mg until a maximum dose of 2000mg daily is reached. After the 4-week titration period, each participant will continue dosing at his or her maximum tolerated dose daily for the remaining 12 weeks of the study.

Group II: Placebo MedicationPlacebo Group1 Intervention

The placebo will be dosed in a weight-dependent manner. Liquid placebo will be provided to any participants unable to swallow the placebo capsules. For participants under 50kg at baseline, the initial dose will be 250mg once per day, and if this dose is well tolerated, they will increase each week by 250mg until a maximum dose of 1000mg daily is reached. For participants at and above 50kg at baseline, the initial dose will be 500mg once per day, and if this dose is well tolerated, they will increase each week by 500mg until a maximum dose of 2000mg daily is reached. After the 4-week titration period, each participant will continue dosing at his or her maximum tolerated dose daily for the remaining 12 weeks of the study.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaOTHER

888 Previous Clinical Trials

384,838 Total Patients Enrolled

1 Trials studying Intellectual Disability

120 Patients Enrolled for Intellectual Disability

St. Justine's HospitalOTHER

196 Previous Clinical Trials

78,909 Total Patients Enrolled

1 Trials studying Intellectual Disability

120 Patients Enrolled for Intellectual Disability

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,463 Total Patients Enrolled

1 Trials studying Intellectual Disability

68 Patients Enrolled for Intellectual Disability

Media Library

Metformin (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT03479476 — Phase 2 & 3

Intellectual Disability Research Study Groups: Active Metformin Medication, Placebo Medication

Intellectual Disability Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT03479476 — Phase 2 & 3

Metformin (Anti-diabetic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03479476 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions does Active Metformin Medication typically target?

"Active Metformin Medication can be leveraged in the treatment of physical activity, type 1 diabetes, and diabetic ketoacidosis."

Answered by AI

Does this research endeavor include participants over 30 years of age?

"To participate in this medical study, patients should be between the ages of 6 and 25. Furthermore, 442 clinical trials are available for children under 18 while 1166 studies exist specifically for adults over 65 years old."

Answered by AI

What previous research efforts have been dedicated to exploring the effectiveness of Active Metformin Medication?

"Currently, 153 clinical trials are in progress to investigate Active Metformin Medication with 36 of them being at Phase 3. While multiple sites for these studies are situated in Rockville, Maryland there is a total of 2020 trial locations worldwide."

Answered by AI

Is enrollment available for this research endeavor?

"According to clinicaltrials.gov, this medical trial's recruitment period has concluded. The study was launched on April 30th 2018 and the most recent data update occurred on August 31st 2022. While not presently recruiting participants, 1666 other studies are currently enlisting patients in research activities."

Answered by AI

Could I potentially be eligible for this research program?

"This trial is seeking 55 individuals living with fragile x syndrome that are aged between 6 and 25 years old. Eligibility requirements include a molecular confirmation of the full FMR1 mutation or mosaicism, male/non-pregnant female sex, an IQ ≤ 79 as measured by the Leiter-III test at screening, ability to speak 3-word phrases occasionally, willingness to comply with study specifications and attend clinic visits regularly, stability in concomitant medication dosage for 4 weeks prior to screening visit plus throughout duration of trial period., behavioural/educational treatments must also be stable over same four week timeframe plus during entire course of study"

Answered by AI

What is the participant size of this research endeavor?

"This particular clinical trial is not open to enrolment at the moment. It was first posted on April 30th 2018 and last updated on August 31st 2022. If you are interested in other trials, there are 1513 studies recruiting for fragile x syndrome and 153 treatments involving active metformin medication that welcome participants presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of Metformin in Individuals With Fragile X Syndrome

2018. "A Trial of Metformin in Individuals With Fragile X Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03479476.

All > Fragile X Syndrome