Clinical trial: Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X Syndrome (NCT02998151)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects ages 15-55, with FXS who completed the study entitled "Mechanisms and brain
             circuits underlying fragile X syndrome (IRB # 2015-8425). FXS is defined as full FMR1
             mutations (>200 CGG repeats) confirmed by genetic testing.

          -  General good health as determined by physical exam, medical history and laboratory
             work up.

        Exclusion Criteria:

          -  Subjects with a history of intolerance to acamprosate, lovastatin, or minocycline will
             be excluded.

          -  Subjects will also be excluded if they have taken any investigational drug within 3
             months, have a history of substance abuse or dependence within 6 months, or
             significant psychiatric or CNS neurological disease unrelated to FXS.

          -  Uncontrolled seizures impact EEG data as do anticonvulsants, barbiturates, lithium and
             benzodiazepines and are exclusions (within 5 half-lives). Those taking other
             psychiatric medications must be on stable doses for 4 weeks before any testing.

          -  For female subjects of child bearing potential, a positive urine pregnancy test.

          -  Potential subjects with a creatinine clearance < 50 mL/min will be excluded.

          -  Identified medical issues, inability to tolerate study procedures or study drug per
             the discretion of the Principal Investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 55 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? Entailment