Status:
COMPLETED
Minocycline to Treat Childhood Regressive Autism
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Autism
Minocycline
Eligibility:
All Genders
3-12 years
Phase:
PHASE4
Brief Summary
There is a subgroup of children with autism that appears to develop typically for a period of time, and then loses social or language skills, or regresses. A recent study by Vargas and co-workers at J...
Detailed Description
Autism is a neurodevelopmental disorder that results in abnormalities of social and language development and is associated with rigid and repetitive behaviors. Although there is strong evidence of her...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- The sample will be children with:
- Diagnosis of idiopathic autism and regression
- Age between 3 and 12 years
- Willingness to undergo lumbar puncture for evaluation of proinflammatory CSF cytokines
- Stable behavioral plus or minus medication therapies.
- EXCLUSION CRITERIA:
- Significant prematurity at birth (less than 32 weeks gestation); or birthweight significantly below normal for gestational age (SGA--small for gestational age).
- Neurologic disorders including cerebral palsy, uncontrolled epilepsy, and Landau-Kleffner syndrome.
- Evidence of renal insufficiency or hepatic disease (to reduce the incidence of side-effects, since minocycline is excreted by the kidneys following hepatic metabolism)
- Increased risk of developing lupus-like syndrome with minocycline administration (positive anti-double stranded DNA or anti-nucleosome antibody tests at baseline, or presence of a first degree relative with S.L.E.)
- Recent (less than two months prior to study entry) initiation of a behavioral therapy program or new psychotropic medication trial.
- Subjects on one of the medications/supplements listed as those with possible interactions or those on high dose B6 supplementation. For those families who are interested in the study but are on any of these medications/supplements at the time of intake, they will be instructed to wean the medication as appropriate (working with the prescribing MD), and they will be enrolled after a 6-week wash-out period.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00409747
Start Date
November 1 2006
End Date
April 1 2011
Last Update
December 11 2015
Active Locations (2)
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1
Childrens National Medical Center
Washington D.C., District of Columbia, United States
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892