A Phase 2 interventional study of Minocycline, then Minocycline/Lovastatin and Lovastatin, then Minocycline/Lovastatin in Fragile X Syndrome, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to participants aged 8 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by Université de Sherbrooke · Phase 2, Interventional, and Treatment
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.
111 studies on the registry are indexed under Fragile X Syndrome; 23 are open to participants now.
This study's enrollment of 22 is below the median of 57 across 89 interventional studies indexed under Fragile X Syndrome.
Browse Fragile X Syndrome studies →Université de Sherbrooke is the lead sponsor of 296 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
Concomitant use of prohibited drugs
Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months.
Drug: Minocycline, then Minocycline/Lovastatin
Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months
Drug: Lovastatin, then Minocycline/Lovastatin
Drug page: Minocycline
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.
Also known as: Minocin
Drug page: 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.
Also known as: Mevacor
Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks
Time frame: baseline, 8 weeks, 12 weeks, 20 weeks
Clinical Global Impression Scale improvement (CGI-I)
Time frame: baseline, 8 weeks, 12 weeks, 20 weeks
Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks
Time frame: baseline, 8 weeks, 20 weeks
Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks
Time frame: baseline, 8 weeks, 20 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Before treatment and at the end of treatment (weeks 20)
Change from baseline Vineland II; adaptive behaviour scale at 20 weeks
Time frame: baseline, 20 weeks
(optional) Change in brain activity using Functional Magnetic Resonance Imaging (fMRI) at 8 and 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.
Time frame: baseline, 8 weeks, 20 weeks
(optional) Change in neurochemistry using Transcranial Magnetic Stimulation (TMS) at 8 and 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.
Time frame: baseline, 8 weeks, 20 weeks
Plan to share: No
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Minocycline · Lovastatin