Clinical trial: Acamprosate in Youth With Fragile X Syndrome (NCT01300923)

Eligibility criteria:
Inclusion Criteria:

          -  Male and female outpatients between the ages of 5 and 17 years.

          -  Confirmed diagnosis of Fragile X Syndrome based upon genetic testing.

          -  Stable dosing of all psychotropic medications for at least 2 weeks prior to baseline.

          -  Subjects with a stable seizure disorder or history of only childhood febrile seizures
             will be included.

          -  Clinical Global Impression-Severity Score of 4 (Moderately Ill) or greater.

          -  Must be in good physical health.

          -  Subjects of child bearing age of both genders will be required to utilize birth
             control as applicable.

        Exclusion Criteria:

          -  Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder or alcohol or
             other substance abuse based on Diagnostic and Statistical Manual Fourth Edition-Text
             Revised (DSM-IV-TR).

          -  A significant medical condition such as heart, liver, renal or pulmonary disease or
             unstable seizure disorder.

          -  Females with a positive urine pregnancy test

          -  Creatinine clearance of less than 30.

          -  Concomitant use of another glutamatergic agent (memantine,riluzole, d-cycloserine,
             amantadine topiramate, gabapentin, among others.

          -  Evidence of hypersensitivity to acamprosate or potentially serious adverse effect.

          -  Subjects who, in the opinion of the investigator, are unsuitable in any other way to
             participate in this study including being unable to comply with the requirements of
             the study for any reason.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 17 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