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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02680379
• Date of registration: 25/01/2016
• Prospective Registration: Yes
• Primary sponsor: Université de Sherbrooke
• Public title: Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome LovaMiX
• Scientific 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)
• Date of first enrolment: March 2016
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02680379
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: François Corbin, MD/PhD
• Affiliation: Fragile X Clinic, Centre de recherche du CHUS

Key inclusion & exclusion 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).



Age minimum: 8 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Fragile X Syndrome

Intervention(s)

Drug: Minocycline, then Minocycline/Lovastatin

Drug: Lovastatin, then Minocycline/Lovastatin

Primary Outcome(s)

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(s)

Change from baseline Vineland II; adaptive behaviour scale at 20 weeks [Time Frame: baseline, 20 weeks]

Clinical Global Impression Scale improvement (CGI-I) [Time Frame: baseline, 8 weeks, 12 weeks, 20 weeks]

Behavior Rating Inventory of Executive Function (BRIEF) [Time Frame: Before treatment and at the end of treatment (weeks 20)]

Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks [Time Frame: baseline, 8 weeks, 20 weeks]

Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks [Time Frame: baseline, 8 weeks, 20 weeks]

Secondary ID(s)

2016-1177

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FRAXA Research Foundation