Status:
COMPLETED
Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome
Lead Sponsor:
FRAXA Research Foundation
Collaborating Sponsors:
Fragile X Research Foundation of Canada
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
13-35 years
Phase:
NA
Brief Summary
Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment, developmental disability and autism. Minocycline is an antibiotic that has recently been used to treat the mouse ...
Detailed Description
Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment and is also associated with a range of learning disabilities, neurological problems, such as seizures, and behavio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00858689
Start Date
October 1 2007
End Date
January 1 2009
Last Update
February 18 2016
Active Locations (1)
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1
Surrey Place Centre
Toronto, Ontario, Canada, M5S 2C2