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NCT01053156 · ClinicalTrials.gov registry record · NA
Trial of Minocycline to Treat Children With Fragile X Syndrome
A NA study of Fragile X Syndrome, sponsored by University of California, Davis.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT01053156: Completed NA study of Fragile X Syndrome, sponsored by University of California, Davis.
NCT01053156 is a NA study of Fragile X Syndrome that has completed, run by University of California, Davis. The registered enrollment target is 66 participants, below the 98-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01053156, a NA study of Fragile X Syndrome, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. We are investigating its use in FXS because it lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also strengthens brain connections in the animal models of FXS. We hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile X patients.
Primary Outcome
The CGI-I utilizes history from primary caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment, from 1 "very much improved" to 7 "very much worse". Lower scores indicate more improvement. Scores were obtained post treatments. Scores from when the patients were on minocycline either first or second were combined and averaged to determine a least squares mean and placebo scores were obtained in the same manner.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG minocycline hydrochloride
Study Locations (1)
California
- M.I.N.D. Institute at University of California at Davis Medical Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-12 |
| Phase | NA |
What the finished NCT01053156 record still lists
NCT01053156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 98-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01053156 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01053156 about?
NCT01053156 is a clinical study titled "Trial of Minocycline to Treat Children With Fragile X Syndrome". This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodeg...
What is the current status of trial NCT01053156?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2010-01. Estimated completion is 2011-12.
What conditions does trial NCT01053156 study?
This clinical trial studies the following conditions: Fragile X Syndrome.
What interventions are being tested in trial NCT01053156?
The interventions under investigation include: Placebo (DRUG), minocycline hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01053156?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01053156 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fragile X Syndrome
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Where NCT01053156's enrollment target sits among peer trials
66 8th of 16 higher than 9 of 16 other Fragile X Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fragile X Syndrome 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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