Fragile X Syndrome
Conditions
Keywords
Fragile X Syndrome, Autism, FMR1, FRAXA
Brief summary
The purpose of this study is to determine whether Lovastatin, Minocycline and the combination Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X individuals.
Interventions
DRUGMinocycline, then Minocycline/Lovastatin
Participants of this group will take 1 tablet of minocycline 50mg daily for 4 weeks, minocycline 100mg for the following 4 weeks and finally a combined treatment of minocycline 100 mg and lovastatin 40mg for the following 12 weeks.
DRUGLovastatin, then Minocycline/Lovastatin
Participants of this group will take 1 tablet of lovastatin 20 mg daily for 4 weeks, lovastatin 40 mg for the following 4 weeks and finally a combined treatment of minocycline 100 mg and lovastatin 40 mg for the following 12 weeks.
Sponsors
FRAXA Research Foundation
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Molecular diagnosis of fragile X syndrome * The participant must be accompanied his parent, legal tutor or legal representative. * Identify a caregiver who spends at least six hours per day with the participant (may be the parent, legal tutor, legal representative or an other person). * IQ \< 70 * ABC-C score \> 20 * CGI-Severity score ≥ 4
Exclusion criteria
* Pregnant or breastfeeding participants * Previous intolerance/allergy to statins, minocycline or tetracyclines * Participants who have taken lovastatin or minocycline in the last 12 weeks * Personal history of myopathy, myalgia or high creatine kinase (CK) levels * Renal disease / liver disease / disturbed hepatorenal tests * Participants taking more than three psychoactive medications (except anticonvulsants) * Untreated or uncontrolled hypothyroidism * Any other active medical condition * Modification of psychoactive treatment in the last 6 weeks prior to randomization * Participants under the age of 13 years who have incomplete formation of the crown of their teeth (except possibly their 3rd molars) as shown by panorex * Concomitant use of prohibited drugs * Prohibited drugs include other hypolipemic including gemfibrozil (or other fibrates) and niacin (nicotinic acid), angiotensin converting enzyme (ACE), cyclosporine, danazol, amiodarone, verapamil and inhibitors P450 (CYP3A4) (itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, inhibitors of HIV protease and nefazodone).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks | baseline, 8 weeks, 12 weeks, 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression Scale improvement (CGI-I) | baseline, 8 weeks, 12 weeks, 20 weeks |
| Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks | baseline, 8 weeks, 20 weeks |
| Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks | baseline, 8 weeks, 20 weeks |
| Behavior Rating Inventory of Executive Function (BRIEF) | Before treatment and at the end of treatment (weeks 20) |
| Change from baseline Vineland II; adaptive behaviour scale at 20 weeks | baseline, 20 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| (optional) Change in brain activity using Functional Magnetic Resonance Imaging (fMRI) at 8 and 20 weeks | baseline, 8 weeks, 20 weeks | fMRI is a non-invasive method of assessing brain activity by detecting signal changes in blood flow and oxygenation known as BOLD (Blood-Oxygen-Level Dependent) contrast imaging. |
| (optional) Change in neurochemistry using Transcranial Magnetic Stimulation (TMS) at 8 and 20 weeks | baseline, 8 weeks, 20 weeks | Using an unpainful magnetic stimulation on the primary motor cortex, TMS will be used to assess intracortical facilitation and inhibition, corresponding respectively to glutamate and GABAergic processes. |
Countries
Canada
Outcome results
None listed