Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01053156
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2010-01-19
Brief Title:
Trial of Minocycline to Treat Children With Fragile X Syndrome
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Randomized Double-Blind Controlled Cross Over Trial of Minocycline in Children With Fragile X Syndrome
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center study at the UC Davis MIND Institute in patients age 35-16 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 andor cognition in fragile X patients
Detailed Description:
This is a single center study at the UC Davis MIND Institute in patients age 35-16 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 andor 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 35 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
The aim of this study is to carry out a double-blind placebo controlled trial of minocycline treatment in children with FXS who are 35 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None