N/A
N=66
Trial of Minocycline to Treat Children With Fragile X Syndrome
Fragile X Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01053156 ↗Enrolled (actual)
66
Serious AEs
0.8%
Results posted
Jul 2014
Primary outcome: Primary: Clinical Global Impression Scale (CGI) — 2.49; 2.97 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- minocycline hydrochloride (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression Scale (CGI) |
2.49; 2.97 | — |
| PRIMARY Visual Analogue Scale- Behavior 1 |
2.28; 4.60; 4.44 | — |
| SECONDARY Visual Analogue Scale- Behaviors 2 |
2.62; 4.91; 4.16 | — |
| SECONDARY Expressive Vocabulary Test-2 |
65.92; 68.86; 67.91 | — |
| SECONDARY Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score |
69.88; 70.85; 71.43 | — |
| SECONDARY Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score |
41.22; 44.22; 41.81 | — |
| SECONDARY Visual Analogue Scale Behavior 3- VAS3 |
2.80; 4.88; 4.13 | — |
| SECONDARY VAS Categorized by Behavior: Aggression/ ADHD |
2.38; 4.49; 4.26 | — |
| SECONDARY VAS Categorized by Behavior:Anxiety/ Mood |
2.47; 5.26; 4.05 | — |
| SECONDARY VAS Categorized by Behavior:Language/ Cognition |
2.58; 4.99; 4.67 | — |
| SECONDARY VAS Categorized by Behavior: Other |
3.49; 5.84; 3.41 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Must have fragile X syndrome with molecular documentation
- Current pharmacological treatment regimen has been stable for at least 4 weeks
Exclusion Criteria
- Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study
- subjects who are unable to take oral medication
- subjects who have been on minocycline previously
- subjects who are allergic to minocycline or tetracyclines
- subjects who are pregnant
- subjects with history of lupus or hepatic dysfunction
Data sourced from ClinicalTrials.gov (NCT01053156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.