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NCT00409747 · ClinicalTrials.gov registry record · Phase 4
Minocycline to Treat Childhood Regressive Autism
A Phase 4 study of Autism and Minocycline, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT00409747: Completed Phase 4 study of Autism and Minocycline, sponsored by National Institute of Mental Health (NIMH).
NCT00409747 is a Phase 4 study of Autism and Minocycline that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 11 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00409747, a Phase 4 study of Autism and Minocycline, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study 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 Johns Hopkins has demonstrated that this regressive type of autism is associated with chronic brain inflammation as shown by an abnormal production of inflammatory cytokines among other abnormalities. This present study will test the effectiveness of minocycline, an antibiotic with anti-inflammatory properties, in treating regressive autism. Although behavioral therapies have improved some symptoms of autism, there are no medical treatments for the disorder, and many children have ongoing behavioral difficulties. A medicine with anti-inflammatory properties may be beneficial for children with regressive autism. This will be an open-label trial, meaning all children in this study will receive minocycline. They will also receive vitamin B6 to reduce the possible chance of side effects of the minocycline. Children ages 3 to 12 with regressive autism may be eligible for this study. The children will take minocycline and vitamin B6 daily for 6 months. Prior to starting the medication and vitamin B6, children will receive a comprehensive diagnostic assessment for autism as well as a physical examination, medical history, and laboratory tests. Children will then receive ongoing assessments to monitor their behavior, communication, language skills, and medical issues at 2 weeks, and at 1, 2, 4, 6, and 12 months. Children who respond to the treatment will receive an additional 3 months of minocycline and vitamin B6.
Primary Outcome
The Mann-Whitney U-test was used to compare pre-/post-treatment differences in analyte concentrations in serum, plasma and CSF. The Mann-Whitney U test generates a z-score test statistic with an associated p value. A negative z-statistic reflects a decrease in analyte level from pre- to post-treatment. Statistical significance level was set at 0.05. There is one test statistic (z-score) per analyte, reflecting the pre-post comparison across all subjects. Pre and post treatment measurements of c
Conditions Studied
Interventions
- DRUG Minocycline
Study Locations (2)
District of Columbia
- Childrens National Medical Center - Washington D.C.
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-11 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
What the finished NCT00409747 record still lists
NCT00409747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Autism appearing as the primary indexed condition, and to 1 intervention - of which Minocycline is the first listed.
NCT00409747 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT00409747 about?
NCT00409747 is a clinical study titled "Minocycline to Treat Childhood Regressive Autism". 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 Johns Hopkins has demonstrated that this regressive type of autism is associated with chronic brain i...
What is the current status of trial NCT00409747?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2006-11. Estimated completion is 2011-04.
What conditions does trial NCT00409747 study?
This clinical trial studies the following conditions: Autism, Minocycline, Regressive Autism.
What interventions are being tested in trial NCT00409747?
The interventions under investigation include: Minocycline (DRUG).
Who is sponsoring clinical trial NCT00409747?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00409747 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00409747's enrollment target sits among peer trials
11 100th of 104 higher than 4 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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