Cited by 224Genetics and Neurodevelopmental DisordersAutism Spectrum Disorder ResearchDown syndrome and intellectual disability research

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Open-label add-on treatment trial of minocycline in fragile X syndrome.

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Paribello, Carlo, Tao, Leeping, Folino, Anthony, Berry-Kravis, Elizabeth, Tranfaglia, Michael, Ethell, Iryna M, Ethell, Douglas W·2010·BMC Neurology

DOI 10.1186/1471-2377-10-91PMC PMC2958860

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Abstract

BACKGROUND: Fragile X syndrome (FXS) is a disorder characterized by a variety of disabilities, including cognitive deficits, attention-deficit/hyperactivity disorder, autism, and other socio-emotional problems. It is hypothesized that the absence of the fragile X mental retardation protein (FMRP) leads to higher levels of matrix metallo-proteinase-9 activity (MMP-9) in the brain. Minocycline inhibits MMP-9 activity, and alleviates behavioural and synapse abnormalities in fmr1 knockout mice, an established model for FXS. This open-label add-on pilot trial was conducted to evaluate safety and efficacy of minocycline in treating behavioural abnormalities that occur in humans with FXS. METHODS: Twenty individuals with FXS, ages 13-32, were randomly assigned to receive 100 mg or 200 mg of minocycline daily. Behavioural evaluations were made prior to treatment (baseline) and again 8 weeks after daily minocycline treatment. The primary outcome measure was the Aberrant Behaviour Checklist-Community Edition (ABC-C) Irritability Subscale, and the secondary outcome measures were the other ABC-C subscales, clinical global improvement scale (CGI), and the visual analog scale for behaviour (VAS). Side effects were assessed using an adverse events checklist, a complete blood count (CBC), hepatic and renal function tests, and antinuclear antibody screen (ANA), done at baseline and at 8 weeks. RESULTS: The ABC-C Irritability Subscale scores showed significant improvement (p < 0.001), as did the VAS (p = 0.003) and the CGI (p < 0.001). The only significant treatment-related side effects were minor diarrhea (n = 3) and seroconversion to a positive ANA (n = 2). CONCLUSIONS: Results from this study demonstrate that minocycline provides significant functional benefits to FXS patients and that it is well-tolerated. These findings are consistent with the fmr1 knockout mouse model results, suggesting that minocycline modifies underlying neural defects that account for behavioural abnormalities. A placebo-controlled trial of minocycline in FXS is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Open-Label Trial NCT00858689.

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Authors: Paribello, C., Tao, L., Folino, A., Berry-Kravis, E., Tranfaglia, M., Ethell, I. M., & Ethell, D. W.
Affiliations: Surrey Place Centre (CA)
Fraxa Research Foundation (US)
University of California, Riverside (US)
Corresponding author: Paribello, Carlo
ORCID: Ethell, Iryna M
Ethell, Douglas W
Venue: BMC Neurology
Publisher: Springer Science and Business Media LLC
Published: 2010-10-11
Volume: 10
Issue: 1
Pages: 91-91
ISSN: 1471-2377 (ISSN-L)
DOI: 10.1186/1471-2377-10-91
PMC: PMC2958860
OpenAlex: W2153053291
Cited by: 223
References: 45
Citations by year: 2026: 3 · 2025: 3 · 2024: 7 · 2023: 5 · 2022: 9 · 2021: 4 · 2020: 15 · 2019: 10 · 2018: 12 · 2017: 20 · 2016: 12 · 2015: 17 · 2014: 26 · 2013: 30 · 2012: 23
FWCI: 14.38
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
www.springer.com/tdm (unspecified)
Locations: BMC Neurology (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: FRAXA Research Foundation
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetics and Neurodevelopmental Disorders
Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Down syndrome and intellectual disability research
Keywords: fragile X syndrome, minocycline, MMP-9, FMRP, behavioural abnormalities, irritability, adjunctive therapy, drug safety, adverse events, antinuclear antibodies, Fmr1 knockout mice
MeSH terms: Adolescent, Adult, Enzyme Inhibitors, Female, Fragile X Syndrome, Humans, Male, Minocycline, Pilot Projects, Treatment Outcome, Young Adult

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Open-label add-on treatment trial of minocycline in fragile X syndrome.

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