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Trial of Minocycline to Treat Children With Fragile X Syndrome

NCT01053156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2017-05-30

Study results available
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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.

Conditions

  • Fragile X Syndrome

Interventions

DRUG

minocycline hydrochloride

Minocycline hydrochloride dosed orally once a day for 3 months.

DRUG

Placebo

Placebo will be given daily for 3 months.

Sponsors & Collaborators

  • The National Fragile X Foundation

    collaborator OTHER

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Randi J Hagerman, MD · M.I.N.D. Institute at University of California at Davis, Sacramento CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
42 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053156 on ClinicalTrials.gov