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Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome (LovaMiX)

Primary Purpose

Fragile X Syndrome

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Minocycline, then Minocycline/Lovastatin
Lovastatin, then Minocycline/Lovastatin
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fragile X Syndrome focused on measuring Fragile X Syndrome, Autism, FMR1, FRAXA

Eligibility Criteria

8 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Centre de Recherche du CHUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Minocycline, then Minocycline/Lovastatin

Lovastatin, then Minocycline/Lovastatin

Arm Description

Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months.

Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months

Outcomes

Primary Outcome Measures

Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks

Secondary Outcome Measures

Clinical Global Impression Scale improvement (CGI-I)
Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks
Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
Change from baseline Vineland II; adaptive behaviour scale at 20 weeks

Full Information

First Posted
January 25, 2016
Last Updated
October 10, 2018
Sponsor
Université de Sherbrooke
Collaborators
FRAXA Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02680379
Brief Title
Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome
Acronym
LovaMiX
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
FRAXA Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fragile X Syndrome
Keywords
Fragile X Syndrome, Autism, FMR1, FRAXA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minocycline, then Minocycline/Lovastatin
Arm Type
Experimental
Arm Description
Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months.
Arm Title
Lovastatin, then Minocycline/Lovastatin
Arm Type
Experimental
Arm Description
Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months
Intervention Type
Drug
Intervention Name(s)
Minocycline, then Minocycline/Lovastatin
Other Intervention Name(s)
Minocin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lovastatin, then Minocycline/Lovastatin
Other Intervention Name(s)
Mevacor
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Clinical Global Impression Scale improvement (CGI-I)
Time Frame
baseline, 8 weeks, 12 weeks, 20 weeks
Title
Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks
Time Frame
baseline, 8 weeks, 20 weeks
Title
Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks
Time Frame
baseline, 8 weeks, 20 weeks
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame
Before treatment and at the end of treatment (weeks 20)
Title
Change from baseline Vineland II; adaptive behaviour scale at 20 weeks
Time Frame
baseline, 20 weeks
Other Pre-specified Outcome Measures:
Title
(optional) Change in brain activity using Functional Magnetic Resonance Imaging (fMRI) at 8 and 20 weeks
Description
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
Title
(optional) Change in neurochemistry using Transcranial Magnetic Stimulation (TMS) at 8 and 20 weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Corbin, MD/PhD
Organizational Affiliation
Fragile X Clinic, Centre de recherche du CHUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche du CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome

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