NCT01053156

Trial of Minocycline to Treat Children With Fragile X Syndrome

Randomized Double-Blind Controlled Cross Over Trial of Minocycline in Children With Fragile X Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 42 Months – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The aim of this study is to carry out a double-blind placebo controlled trial of minocycline treatment in children with FXS who are 3.5 to 16 years of age. At baseline, we will assess behavior and perceptual and cognitive development. After the children have been treated for 3 months with either minocycline or placebo, they undergo the same baseline testing. They will then cross over and be treated for a second 3 months. We will carry out testing again at the end of the second 3 month period. We will also assess the side effects of minocycline treatment throughout the study.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	minocycline hydrochloride	Minocycline hydrochloride dosed orally once a day for 3 months.
DRUG	Placebo	Placebo will be given daily for 3 months.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-01-21
• Last updated: 2017-05-30
• Results posted: 2014-07-30

Locations

1 site across 1 country: United States