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

Université de Sherbrooke

Status and phase: Completed; Phase 2

Conditions: Fragile X Syndrome

Treatments: Drug: Lovastatin, then Minocycline/Lovastatin; Drug: Minocycline, then Minocycline/Lovastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02680379

2016-1177

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 8 to 45 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

Minocycline, then Minocycline/Lovastatin

Experimental group

Description:

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

Treatment:

Drug: Minocycline, then Minocycline/Lovastatin

Lovastatin, then Minocycline/Lovastatin

Experimental group

Description:

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

Treatment:

Drug: Lovastatin, then Minocycline/Lovastatin