Metformin in Children and Adults With Fragile X Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT03722290
• Date of registration: 24/10/2018
• Prospective Registration: No
• Primary sponsor: Université de Sherbrooke
• Public title: Metformin in Children and Adults With Fragile X Syndrome
• Scientific title: Evaluate the Efficacy and Safety of Metformin in Children and Adults With Fragile X Syndrome: an Open-label Study
• Date of first enrolment: September 1, 2018
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03722290
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged between 10 et 45 years old

- BMI > 18.3

- Molecular diagnosis of FXS

- Accompanied by his legal tutor

Exclusion Criteria:

- Pregnancy/Breastfeeding

- Intolerance to metformin

- History of lactic acidosis

- Gastric/renal/hepatic pathology

- Acute medical condition

- Concomitant use of ACE inhibitors

- Modification of antipsychotic treatments in the last 6 weeks



Age minimum: 10 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Fragile X Syndrome

Intervention(s)

Drug: Metformin

Primary Outcome(s)

Change from baseline in the total score of the FX-normed Aberrant Behavior Checklist-Community after 9 weeks of metformin treatment [Time Frame: Baseline, Week 9]

Incidence of adverses events reported during the study [Time Frame: 9 weeks]

Secondary Outcome(s)

Changes from baseline in the score of each subscale of the Aberrant Behavior Checklist-Community (ABC-C) [Time Frame: Baseline, Week 9]

Changes from baseline in the Global Executive Composite (GEC) baseline score of the Behavior Rating Inventory of Executive Function (BRIEF) [Time Frame: Baseline, Week 9]

Level of cortical excitability using Transcranial Magnetic Stimulation (TMS) [Time Frame: Baseline, Week 9]

Changes from baseline in the score of 4 subtests of the computerized cognitive Test of Attentional Performance for Children [Time Frame: Baseline, Week 9]

Level of synaptic plasticity using Electroencephalography (EEG) [Time Frame: Baseline, Week 9]

Secondary ID(s)

2019-2797

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FRAXA Research Foundation