Status:
COMPLETED
A Trial of Metformin in Individuals With Fragile X Syndrome
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
University of Alberta
St. Justine's Hospital
Conditions:
Fragile X Syndrome
Fragile X Mental Retardation Syndrome
Eligibility:
All Genders
6-25 years
Phase:
PHASE2
PHASE3
Brief 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 plac...
Detailed Description
This is a multi-site study for fragile X syndrome (FXS) patients aged 6 to 25 years inclusive. It is a randomized, double-blind, placebo-controlled trial of metformin (also known as Glumetza, Glucopha...
Eligibility Criteria
Inclusion
- Molecular genetic confirmation of the full FMR1 mutation or mosaicism.
- Males and non-pregnant, non-lactating females age 6 to 25 years, inclusive.
- Ability of subject and/or caregiver to understand, read, write, and speak English fluently to complete study-related materials.
- IQ ≤ 79 as measured by the Leiter-III at screening.
- Participant is able to speak at least occasional 3-word phrases.
- Participant and parent/caregiver are willing to participate in the protocol and able to attend the clinic regularly and reliably.
- Stable concomitant medication dose and dosing regimen for at least 4 weeks prior to the screening/baseline visit, and the intention to maintain a stable regimen of allowed concomitant medications for the full duration of the study.
- Stable behavioral/educational treatments for at least 4 weeks prior to the screening/baseline visit.
- Sexually active women of childbearing potential must be using a medically acceptable method of birth control for the duration of the study and have a negative urine pregnancy test collected at the initial screening/baseline visit.
- For participants who are not their own legal guardian, the parent/legal authorized representative is able to understand and sign an informed consent to participate in the study.
Exclusion
- Non-cooperation or inability to follow through with the study protocol.
- Life-threatening medical problem or other major systemic illness that compromises health or safety and/or would interfere with the study.
- History of intolerable adverse events with metformin.
- Current or recent metformin treatment (within the past year).
- Body mass index (BMI) less than 2 standard deviations for age.
- Serum creatinine \> 1.4 mg/dl (female) or \> 1.5 mg/dl (male) at screening.
- History of metabolic acidosis or a condition with lactic acidosis.
- Severe B12 deficiency.
- Pregnancy at screening or unwillingness to use acceptable method of birth control, if applicable.
Key Trial Info
Start Date :
April 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03479476
Start Date
April 30 2018
End Date
May 22 2024
Last Update
January 17 2025
Active Locations (3)
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1
UC Davis MIND Institute
Sacramento, California, United States, 95817
2
University of Alberta
Edmonton, Alberta, Canada, T6G2R3
3
St Justine Hospital
Montreal, Quebec, Canada, H3T 1C5