Fragile X Syndrome Clinical Trial
Official title:
Randomized Double-Blind Controlled Cross Over Trial of Minocycline in 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 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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05418049 -
Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge
|
Phase 2 | |
Enrolling by invitation |
NCT01364818 -
Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
|
N/A | |
Completed |
NCT00965432 -
A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
|
Phase 1 | |
Completed |
NCT01120626 -
Randomized Controlled Study of Donepezil in Fragile X Syndrome
|
Phase 2 | |
Completed |
NCT01204151 -
Teaching Math Skills to Individuals With Fragile X Syndrome
|
N/A | |
Active, not recruiting |
NCT00334971 -
Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women
|
N/A | |
Enrolling by invitation |
NCT06139172 -
Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities
|
N/A | |
Recruiting |
NCT04977986 -
Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome
|
Phase 3 | |
Active, not recruiting |
NCT04698551 -
NIPD on cffDNA for Triplet Repeat Diseases
|
||
Completed |
NCT03722290 -
Metformin in Children and Adults With Fragile X Syndrome
|
Phase 2 | |
Completed |
NCT05030129 -
Single Blind Study of Ergoloid Mesylates, 5-HTP and the Combination in Adult Males With Fragile X Syndrome
|
Phase 2 | |
Recruiting |
NCT05957549 -
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG
|
N/A | |
Recruiting |
NCT04141163 -
Metformin in Patients With Fragile X
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06081348 -
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
|
Phase 2 | |
Completed |
NCT00858689 -
Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome
|
N/A | |
Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
Enrolling by invitation |
NCT03802799 -
Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS
|
Phase 2/Phase 3 | |
Recruiting |
NCT05295277 -
Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort
|
||
Enrolling by invitation |
NCT03836300 -
Parent and Infant Inter(X)Action Intervention (PIXI)
|
N/A | |
Completed |
NCT01725152 -
Ganaxolone Treatment in Children With Fragile X Syndrome
|
Phase 2 |