Clinical trial: Open Label Study Investigating Safety and Efficacy of NPL2009 50 mg - 150 mg on Prepulse Inhibition Tests and Continuous Performance Tasks, Adults With Fragile X Syndrome (NCT00637221)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female patients, 18 to 45 years of age.

          -  Diagnosis of Fragile X Syndrome.

          -  Females must demonstrate a negative pregnancy test at screening.

          -  Females of child-bearing potential must be using a medically accepted means of
             contraception or must remain abstinent for the duration of the study.

          -  Each Legally Authorised Representative (LAR, usually parent or caregiver) must have a
             level of understanding sufficient to provide written informed consent to all required
             study tests and procedures.

          -  Each patient must consent/assent (depending on center-specific procedures) to all
             required study tests and procedures.

          -  Permitted concomitant medications must be stable for at least 6 weeks prior to
             enrollment. The following concomitant medications are permitted: psychostimulants,
             SSRIs, atypical antipsychotics, anticonvulsants which do not have liver inducing
             effects, clonidine.

          -  Each patient must be able to swallow the capsules (2, 3 or 4) to be provided in the
             study.

        Exclusion Criteria:

          -  Current treatment with anticonvulsants known to induce liver enzymes e.g. depakote

          -  Current treatment with N-methyl-D-aspartate (NMDA) antagonists

          -  Current treatment with tricyclic antidepressants

          -  Current treatment with typical antipsychotics

          -  Current treatment with lithium

          -  Patients planning to commence cognitive behaviour therapy during the period of the
             study or those who have begun cognitive behavioural therapy within 6 weeks prior to
             enrolment.

          -  History of, or current cardiovascular, renal, hepatic, respiratory and particularly
             gastrointestinal disease which may interfere with the absorption, distribution,
             metabolism or excretion of the study medication.

          -  History of, or current cerebrovascular disease or brain trauma.

          -  History of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism.

          -  History of, or current malignancy.

          -  Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder,
             or other psychotic disorder, as assessed by the Investigator.

          -  Current major depressive disorder (patients must be free of the disorder for 3 months
             prior to enrolment).

          -  Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or
             other factors), as assessed by the Investigator.

          -  Tourette's Disorder.

          -  Female patients who are either pregnant or nursing.

          -  Current drug abuse or dependence disorder or dependency in the 3 months prior to
             enrolment.

          -  Clinically significant abnormalities in safety laboratory tests, vital signs or EKG,
             as measured at screening

          -  Patients with significant hearing and/or visual impairments that may affect their
             ability to complete the test procedures

          -  Enrollment in another clinical trial within the previous 30 days
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? Contradiction