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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
Sponsor:
Collaborator:
FRAXA Research Foundation
Information provided by (Responsible Party):
Francois Corbin, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Fragile X Syndrome Drug: Minocycline, then Minocycline/Lovastatin Drug: Lovastatin, then Minocycline/Lovastatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Clinical Global Impression Scale improvement (CGI-I) [ Time Frame: baseline, 8 weeks, 12 weeks, 20 weeks ]
  2. Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ]
  3. Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ]
  4. Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Before treatment and at the end of treatment (weeks 20) ]
  5. Change from baseline Vineland II; adaptive behaviour scale at 20 weeks [ Time Frame: baseline, 20 weeks ]

Other Outcome Measures:
  1. (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.

  2. (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.



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Ages Eligible for Study:   8 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Centre de Recherche du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
FRAXA Research Foundation
Investigators
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Principal Investigator: François Corbin, MD/PhD Fragile X Clinic, Centre de recherche du CHUS

Additional Information:
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Responsible Party: Francois Corbin, Dr Francois Corbin, MD, PHD, FRCPC, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02680379     History of Changes
Other Study ID Numbers: 2016-1177
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Francois Corbin, Université de Sherbrooke:
Fragile X Syndrome
Autism
FMR1
FRAXA

Additional relevant MeSH terms:
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Syndrome
Fragile X Syndrome
Disease
Pathologic Processes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Minocycline
Lovastatin
L 647318
Dihydromevinolin
Anti-Bacterial Agents
Anti-Infective Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors