Clinical trial: Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome (NCT02680379)

Eligibility 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).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination.  The boy is going to a school for students with learning disabilities.  The patient was adopted, and his immunizations are up to date.  Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value      Normal Range     Patient Value
Glucose                    90-120 mg/dl     95 mg/dl
BUN (Blood Urea Nitrogen)  7-24 mg/dl       10 mg/dl
Creatinine                 0.7-1.4 mg/dl    0.8 mg/dl
Calcium                    8.5-10.5 mg/dl   9 mg/dl
Sodium                     134-143 mEq/L    135 mEq/L
Potassium                  3.5-4.5 mEq/L    3.7 mEq/L
Chloride                   95-108 mEq/L     98 mEq/L
CO2                        20-30 mEq/L      25 mEq/L
Blood pH                   7.38-7.42        7. 39

Patient description (patient's own words): My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range.

Does the patient match the trial criteria? 1