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A Trial of Metformin in Individuals With Fragile X Syndrome

NCT03479476 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-17

No results posted yet for this study

Summary

This study is a controlled trial of metformin in individuals with fragile X syndrome between the ages of 6 and 25 years. Participants will be randomized in a double-blind design to either drug or placebo and will attend three visits to the study site in a 4-month period for a series of tests. The primary objectives are to assess safety, tolerability, and efficacy of metformin in the treatment of language deficits, behavior problems, and obesity/excessive appetite in individuals with fragile X syndrome.

Conditions

  • Fragile X Syndrome
  • Fragile X Mental Retardation Syndrome
  • Mental Retardation, X Linked
  • Genetic Diseases, X-Linked
  • Trinucleotide Repeat Expansion
  • Fra(X) Syndrome
  • Intellectual Disability
  • FXS
  • Neurobehavioral Manifestations
  • Sex Chromosome Disorders

Interventions

DRUG

Placebo Medication

Placebo liquid or capsules given in parallel to active medication.

DRUG

Metformin

Active medication.

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER

  • St. Justine's Hospital

    collaborator OTHER

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Randi J Hagerman, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2024-05-22
Completion
2024-05-22
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03479476 on ClinicalTrials.gov