Clinical trial: Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome (NCT00858689)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of FXS by clinical evaluation and confirmed by FMR1-DNA testing with
             presence of full mutation or mosaicism for the full mutation. Prior DNA testing
             reports will be accepted, when available.

          -  Age between 13 to 35 years inclusive at the time of informed consent.

          -  Male or female

          -  CGI-Severity Score of 4 or greater, indicative of moderate or greater severity of
             behavioural problems. This is a 7-point scale of clinical global impression of
             severity that the clinician fills out after considering all the available information
             on the patient, including the parent history, the examination in clinic, reports from
             the school and other sources.

          -  Score of 9 or greater on the Aberrant Behaviour Checklist - Irritability Scale (top
             50th %-tile). The ABC is a global behaviour checklist implemented for the measurement
             of drug and other treatment effects in mentally impaired individuals. It is made up of
             5 empirically derived dimensions including irritability, lethargy/withdrawal,
             inappropriate speech, hyperactivity, and stereotypic behaviour based on 58 items that
             describe various behavioural problems.

          -  Availability of parent and/or caregiver for all clinic visits and assessments.

          -  English language fluency and reading level of 6th grade or greater in one caregiver.

        Exclusion Criteria:

          -  Allergy to minocycline.

          -  Kidney disease or elevated renal function tests.

          -  Liver disease or elevated liver function tests.

          -  Participants with neutropenia, anemia, or thrombocytopenia.

          -  History of systemic lupus erythematosus or screening anti-nuclear antibody (ANA) titre
             of >1:40, as minocycline may cause a lupus-like reaction.

          -  Individuals who do not have a mother or caregiver who is willing to participate in the
             clinic visits.

          -  Individuals who are pregnant or at risk to become pregnant, specifically sexually
             active females will be excluded.

          -  Presence of persistent psychotic symptoms

          -  Subjects with symptom severity likely judged to endanger personal safety or safety of
             others.

          -  History of systemic lupus erythematosus or screening anti-nuclear antibody (ANA) titre
             of >1:40, as minocycline may cause a lupus-like reaction.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 35 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