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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Fragile X Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minocycline, then Minocycline/Lovastatin

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

Group Type EXPERIMENTAL

Minocycline, then Minocycline/Lovastatin

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Lovastatin, then Minocycline/Lovastatin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Minocin Mevacor

Eligibility Criteria

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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).

Minimum Eligible Age

8 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No