Metformin in Children and Adults With Fragile X Syndrome
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|ClinicalTrials.gov Identifier: NCT03722290|
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fragile X Syndrome||Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label trial|
|Masking:||None (Open Label)|
|Official Title:||Evaluate the Efficacy and Safety of Metformin in Children and Adults With Fragile X Syndrome: an Open-label Study|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Metformin 500mg twice a day per os for 9 weeks
Oral administration of metformin 250mg (twice a day) for the 1st week followed by metformin 500mg (twice a day) for the next 8 weeks.
Other Name: Glucophage
- Incident of adverses events reported during the study [ Time Frame: 9 weeks ]Number and severity of adverse events related to metformin treatment
- 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 ]The ABC-C is a 58-item caregiver-rated behavior scale where each item ranges from 0 (not a problem) to 3 (severe problem).
- Level of cortical excitability using Transcranial Magnetic Stimulation (TMS) [ Time Frame: Baseline, Week 9 ]The effects of metformin on cortical excitability will be measured using a magnetic stimulation on the primary motor cortex to assess intracortical facilitation and inhibition
- Level of synaptic plasticity using Electroencephalography (EEG) [ Time Frame: Baseline, Week 9 ]The effects of metformin on synaptic plasticity will be measured using the changes in amplitude of EEG waves
- Changes from baseline in the score of each subscale of the Aberrant Behavior Checklist-Community (ABC-C) [ Time Frame: Baseline, Week 9 ]Determining if metformin lowers the score of each subscale of the ABC-C: Irritability (18 items), hyperactivity (10 items), lethargy (16 items), social avoidance (4 items), stereotypy (6 items) and inappropriate speech (4 items). Each item is scored from 0 (not a problem) to 3 (severe problem).
- 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 ]The BRIEF is a 86-item questionary evaluating executive functions rated on a 3-point Likert scale: 1 (never), 2 (sometimes) and 3 (often).
- Changes from baseline in the score of 4 subtests of the computerized cognitive Test of Attentional Performance for Children [ Time Frame: Baseline, Week 9 ]KiTAP is a computerized continuous test of attention assessing the ability to maintain attention in the presence of distractors. The 4 subtests used are Alertness reaction time, Distractibility commission errors, Go/No-Go commission errors and Flexibility errors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722290
|Contact: Artuela Çaku, MD||819-346-1110 ext 71035||Artuela.firstname.lastname@example.org|
|Université de Sherbrooke||Recruiting|
|Sherbrooke, Quebec, Canada, J1H 5H3|
|Contact: Artuela Çaku, MD 819-346-1110 ext 71035 Artuela.s.çaku@usherbrooke.ca|