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| Name | Class |
|---|---|
| FRAXA Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline, then Minocycline/Lovastatin | Experimental | Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months. |
|
| Lovastatin, then Minocycline/Lovastatin | Experimental | Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline, then Minocycline/Lovastatin | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| (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. | baseline, 8 weeks, 20 weeks |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| François Corbin, MD/PhD | Fragile X Clinic, Centre de recherche du CHUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche du CHUS | Sherbrooke | Quebec | J1H 5N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39248107 | Derived | Morin-Parent F, Champigny C, Cote S, Mohamad T, Hasani SA, Caku A, Corbin F, Lepage JF. Neurophysiological effects of a combined treatment of lovastatin and minocycline in patients with fragile X syndrome: Ancillary results of the LOVAMIX randomized clinical trial. Autism Res. 2024 Sep;17(9):1944-1956. doi: 10.1002/aur.3222. Epub 2024 Sep 9. |
| Label | URL |
|---|---|
| Investigator profile | View source |
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| ID | Term |
|---|---|
| D005600 | Fragile X Syndrome |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| D008148 | Lovastatin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Lovastatin, then Minocycline/Lovastatin | Drug | 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. |
|
|
| 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 |
| (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. |
| baseline, 8 weeks, 20 weeks |
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009281 | Naphthalenes |