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

Phase 2

Completed

• Conditions: Fragile X Syndrome
• Interventions: Drug: Lovastatin, then Minocycline/Lovastatin; Drug: Minocycline, then Minocycline/Lovastatin

• Registration Number: NCT02680379
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-11
• Study Start: 2016-03
• Primary Completion: 2017-10
• Study Completion: 2017-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lovastatin, then Minocycline/Lovastatin	Lovastatin, then Minocycline/Lovastatin	Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months
Minocycline, then Minocycline/Lovastatin	Minocycline, then Minocycline/Lovastatin	Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline Social Responsiveness Scale (SRS) at 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)
Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks	baseline, 8 weeks, 20 weeks
Clinical Global Impression Scale improvement (CGI-I)	baseline, 8 weeks, 12 weeks, 20 weeks
Change from baseline Vineland II; adaptive behaviour scale at 20 weeks	baseline, 20 weeks

Trial Locations

Locations (1)

Centre de Recherche du CHUS; 🇨🇦 Sherbrooke, Quebec, Canada