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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

Tracking Information
First Submitted Date  ICMJE January 25, 2016
First Posted Date  ICMJE February 11, 2016
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
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 ]
The questionnaire evaluates the following areas: irritability, lethargy / social withdrawal, inappropriate language, hyperactivity and stereotyped behavior.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • Clinical Global Impression Scale (CGI) severity and improvement [ Time Frame: baseline, 8 weeks, 12 weeks, 20 weeks ]
    The CGI use history of caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment.
  • Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ]
    The SRS are five sub-scales: social awareness, the cognitive, communication with others (the ability to have a discussion), social motivations and mannerisms autistic.
  • Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ]
    ADAMS was developed to study the anxiety, depression and strange mania in individuals with intellectual disabilities of all kinds.
  • Change from baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ]
    This test will be useful in assessing cognitive function of FXS individuals in different areas such as attention, language, short and long term memory, and visuospatial and construction capabilities.
  • Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Before treatment and at the end of treatment (weeks 20) ]
    The questionnaire BRIEF is used to assess the behavior associated with the domain of executive functions.
  • The Social Communication Questionnaire (SCQ) [ Time Frame: baseline ]
    The SCQ is used to identify problems with social relationships, communication and restricted behaviors, stereotyped and repetitive, traits of autism spectrum disorder.
  • Change from baseline Vineland II; adaptive behaviour scale at 20 weeks [ Time Frame: baseline, 20 weeks ]
    This test measures, according to an adaptive behavior scale; social skills, autonomy and communication.
Current Other Pre-specified Outcome Measures
 (submitted: February 22, 2016)
  • (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.
Original Other Pre-specified Outcome Measures
 (submitted: February 10, 2016)
  • Change from baseline Functional Magnetic Resonance Imaging (fMRI) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ]
    This imaging allows to observe changes in brain activity with or without treatment.
  • Change from baseline Transcranial magnetic stimulation (TMS) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ]
    This procedure measures the integrity of the cerebral cortex, with the reflex upon stimulation of the cortex.
  • Change from baseline characterization of blood biomarkers at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ]
    Biomarkers are promising clinical evaluation tools and may measure the effects of a treatment.
 
Descriptive Information
Brief Title  ICMJE Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fragile X Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Minocycline, then Minocycline/Lovastatin
    Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months.
    Intervention: Drug: Minocycline, then Minocycline/Lovastatin
  • Experimental: Lovastatin, then Minocycline/Lovastatin
    Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months
    Intervention: Drug: Lovastatin, then Minocycline/Lovastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2016)
26
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02680379
Other Study ID Numbers  ICMJE 2016-1177
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Francois Corbin, Université de Sherbrooke
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE FRAXA Research Foundation
Investigators  ICMJE
Principal Investigator: François Corbin, MD/PhD Fragile X Clinic, Centre de recherche du CHUS
PRS Account Université de Sherbrooke
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP