Clinical trial: Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome (NCT02642653)

Eligibility criteria:
Inclusion Criteria:

          -  Documentation of a full mutation with absence or deficient FMRP levels.

          -  Males and females ages 10 through 17 years

          -  Willingness of potential study participant as well as a parent or caretaker to
             participate in the protocol.

          -  Speech is the primary means of communication with three-word or longer utterances used
             on a daily basis.

          -  Intelligence quotient (IQ) ≤70 as measured by the Leiter- R.

          -  Sexually active women of childbearing potential (WCBP) must be using a medically
             acceptable method of birth control and have a negative qualitative serum β-human
             chorionic growth hormone (β-HCG) or urine pregnancy test collected at the initial
             screening visit.

        Exclusion Criteria:

          -  Persons who do not speak English.

          -  Changes in any medications (including investigational medications) within the last
             month (4 weeks). All concomitant medications must have been on a stable course for at
             least 4 weeks prior to enrollment into the study and maintain stability throughout the
             course of the study.

          -  Changes in behavioral therapy or educational programming during the study. This does
             not include scheduled school holidays.

          -  Have any disease or condition (medical or surgical) at screening that might compromise
             the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic
             systems; or other conditions that might interfere with the absorption, distribution,
             metabolism, or excretion of the investigational product, or would place the subject at
             increased risk.

          -  Patients 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 or displaying clinically significant abnormalities in safety assessments at
             screening.

          -  Patients on prohibited medications

          -  History of recurrent status epilepticus.

          -  Inability to withhold grapefruit and grapefruit juice from diet during the entire
             clinical trial.

          -  Subjects unwilling to abstain from alcoholic beverages during the trial.

          -  Subjects who are actively suicidal.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 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? Entailment