Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome (LovaMiX)
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|ClinicalTrials.gov Identifier: NCT02680379|
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fragile X Syndrome||Drug: Minocycline, then Minocycline/Lovastatin Drug: Lovastatin, then Minocycline/Lovastatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Exploring the Safety and Synergistic Effect of a Minocycline/Lovastatin Combined Treatment on the Behavior of Individuals With Fragile X Syndrome; Validation of New Biochemical and Neurophysiological Markers (LovaMiX)|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Minocycline, then Minocycline/Lovastatin
Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months.
Drug: Minocycline, 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.
Other Name: Minocin
Experimental: Lovastatin, then Minocycline/Lovastatin
Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months
Drug: Lovastatin, 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.
Other Name: 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 [ Time Frame: 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 [ Time Frame: 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.
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): NCT02680379
|Centre de Recherche du CHUS|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||François Corbin, MD/PhD||Fragile X Clinic, Centre de recherche du CHUS|