Trial record 2 of 3 for:    minocycline and autism

Trial of Minocycline to Treat Children With Fragile X Syndrome

This study has been completed.
Sponsor:
Collaborator:
The National Fragile X Foundation
Information provided by (Responsible Party):
Randi J. Hagerman, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01053156
First received: January 19, 2010
Last updated: April 10, 2012
Last verified: March 2012

January 19, 2010
April 10, 2012
January 2010
December 2011   (final data collection date for primary outcome measure)
  • Clinical Global Impression Scale (CGI) [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Visual Analogue [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01053156 on ClinicalTrials.gov Archive Site
  • Visual Studies - Contrast detection protocol [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Face Processing and Pupillometry protocol [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale (CGI) [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • ADHD Rating Scale-IV [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Kinder-Testbatterie zur Aufmerksamkeitsprüfung (KITAP) [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Prepulse Inhibition protocol (PPI) [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Expressive Vocabulary Test [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Side Effect Scale [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: Yes ]
  • Autism Diagnostic Observation Scale (ADOS) [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Stanford Binet V or the Mullen Scales of Early Learning [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Vineland Adaptive Behavior Scale-II (VABS-II) [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist-Community Edition (ABC-C) [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Visual Studies - Contrast detection protocol [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Face Processing and Pupillometry protocol [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Visual Analogue [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale (CGI) [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • ADHD Rating Scale-IV [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Kinder-Testbatterie zur Aufmerksamkeitsprüfung (KITAP) [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Prepulse Inhibition protocol (PPI) [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Expressive Vocabulary Test [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Side Effect Scale [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: Yes ]
  • Autism Diagnostic Observation Scale (ADOS) [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Stanford Binet V or the Mullen Scales of Early Learning [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Vineland Adaptive Behavior Scale-II (VABS-II) [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist-Community Edition (ABC-C) [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Fragile X Syndrome
  • Drug: minocycline hydrochloride
    Minocycline hydrochloride dosed orally once a day for 3 months.
  • Drug: Placebo
    Placebo will be given daily for 3 months.
  • Placebo Comparator: Placebo pill
    All patients will be on placebo for 3 months in this crossover study.
    Intervention: Drug: Placebo
  • Experimental: Minocycline
    All patients will be on minocycline for 3 months in this crossover trial.
    Intervention: Drug: minocycline hydrochloride
Bilousova TV, Dansie L, Ngo M, Aye J, Charles JR, Ethell DW, Ethell IM. Minocycline promotes dendritic spine maturation and improves behavioural performance in the fragile X mouse model. J Med Genet. 2009 Feb;46(2):94-102. Epub 2008 Oct 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
42 Months to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01053156
200917522-1
Yes
Randi J. Hagerman, MD, University of California, Davis
University of California, Davis
The National Fragile X Foundation
Principal Investigator: Randi J Hagerman, MD M.I.N.D. Institute at University of California at Davis, Sacramento CA
University of California, Davis
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP