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

Fragile X Syndrome Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680379
• Other study ID #: 2016-1177
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: November 2017

Study information

• Verified date: October 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fragile X Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Centre de Recherche du CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	FRAXA Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	(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
Other	(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
Primary	Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks		baseline, 8 weeks, 12 weeks, 20 weeks
Secondary	Clinical Global Impression Scale improvement (CGI-I)		baseline, 8 weeks, 12 weeks, 20 weeks
Secondary	Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks		baseline, 8 weeks, 20 weeks
Secondary	Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks		baseline, 8 weeks, 20 weeks
Secondary	Behavior Rating Inventory of Executive Function (BRIEF)		Before treatment and at the end of treatment (weeks 20)
Secondary	Change from baseline Vineland II; adaptive behaviour scale at 20 weeks		baseline, 20 weeks

External Links

•   Investigator profile