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Metformin in Patients With Fragile X | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

Metformin in Patients With Fragile X

A Parallel Group Design Randomized Double-Blind Trial of Metformin Treatment in Patients With Fragile X Syndrome on Safety and Effects on Cognition, Anxiety, Attention and Biomarkers

NCT04141163•Rowan University

View on ClinicalTrials.gov

Summary

The purpose of this trial is to investigate the use of metformin in the treatment of Fragile X syndrome (FXS) patients. Metformin is an FDA approved compound with an established safety profile and minimal side effects that specifically targets and normalizes multiple aspects of the pathophysiology in FXS. This is a randomized double-blind placebo-controlled 2-arm parallel group design study of the drug metformin and placebo in FXS subjects with a primary outcome measure of safety/tolerability and secondary outcome measures on cognition, attention, anxiety, sleep, and physiologic and biochemical biomarkers.

Detailed Description

This trial will be a randomized placebo controlled, double-blind, parallel group design study of treatment with metformin on the primary outcome of safety/tolerance with secondary outcome measurements of the effects on cognition (encompassing social and repetitive behavior), attention, anxiety, and physiological and biochemical biomarkers of patients with FXS. FXS represents a well-defined population of ASD in which to test a specific targeted treatment looking at a well-defined set of cognitive and bioassay measures. Trial length is designed to have a chance at seeing if the medication can improve cognitive outcome measures. The study duration includes the screening period and a 24-week single-blind drug/placebo phase.

Eligibility

Age

18 - 50 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Male between the ages of 16-50 years old at the time of consent
•Diagnosis of full mutation FXS.
•Stable on any psychoactive medication for at least 4 weeks before receiving study drug, including antidepressants, stimulants, antipsychotics, and mood stabilizers.
•Seizure free for at least the past 3 months.
•No major health issues or diseases expected to interfere with the study
•No history of diabetes
•Not currently taking metformin at the time of enrollment
•Average basal blood glucose HgbA1c \< 7.0
•Study partner with frequent contact with patient willing to accompany patient to visits and complete caretaker/partner study forms
•No contraindication to metformin
+1 more criteria

Exclusion Criteria

•Has a medical condition that would make treatment unsafe such as diabetes, pancreatic disease, liver or kidney disease, a history of epilepsy or seizure disorder that is not controlled, as well as any other medical condition as determined by the study doctor.
•Has an eating disorder that has been clinically diagnosed, predisposing them to low BMI.
•Has received any investigational compound within 30 days prior to the first dose of study medication.
•Has received metformin in a previous clinical study or as a therapeutic agent.
•Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
•Has uncontrolled, clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
•Has a known hypersensitivity to any component of the formulation of metformin.
•Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 6 months prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
•Currently taking any excluded medication, supplements, or food products, or has taken any in the 3 weeks preceding Visit 1. This includes carbonic anhydrase inhibitors and the medication topamax.
•Has evidence of current cardiovascular, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking metformin or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to uncontrolled seizure disorders, and cardiac arrhythmias.
+9 more criteria

Locations (1)

Rowan University School of Osteopathic Medicine

Stratford, New Jersey, United States

Key Dates

Start Date

October 29, 2019

Primary Completion Date

March 1, 2021

Completion Date

March 1, 2021

Last Updated

October 31, 2019

Enrollment

ESTIMATED participants

Conditions

Fragile X Syndrome

Interventions

Metformin

DRUG

Placebo oral tablet

DRUG

Contacts

Lauren Fedor

CONTACT

856-566-6003 fedor@rowan.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metformin in Patients With Fragile X

Inclusion Criteria

Exclusion Criteria

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