Effect of CX516, an AMPA-Modulating Compound, on Cognition and Behavior in Fragile X Syndrome: AControlled Trial

Berry-Kravis, Elizabeth; Krause, Sue Ellen; Block, Sandra S.; Guter, Steve; Wuu, Joanne; Leurgans, Sue; Decle, Penelope; Potanos, Kristina; Cook, Edwin; Salt, Jeff; Maino, Dominick; Weinberg, Dahlia; Lara, Rebecca; Jardini, Tristan; Cogswell, Jennifer; Johnson, Steven A.; Hagerman, Randi

doi:10.1089/cap.2006.16.525

Cited by 155Genetics and Neurodevelopmental DisordersNeuroscience and Neuropharmacology ResearchAutism Spectrum Disorder Research

Effect of CX516, an AMPA-Modulating Compound, on Cognition and Behavior in Fragile X Syndrome: AControlled Trial

Berry-Kravis, Elizabeth, Krause, Sue Ellen, Block, Sandra S., Guter, Steve, Wuu, Joanne, Leurgans, Sue, Decle, Penelope, Potanos, Kristina +9 more·2006·Journal of Child and Adolescent Psychopharmacology

DOI 10.1089/cap.2006.16.525

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Abstract

A Phase II, 4-week randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the safety and efficacy of the Ampakine compound CX516 as a potential treatment for the underlying disorder in fragile X syndrome (FXS). After baseline screening, subjects with FXS (n = 49) underwent a 1-week placebo lead-in and then were randomized to study drug or placebo for a 4-week period. Cognitive and behavioral outcome measures were administered prior to treatment, at the end of treatment, and 2 weeks posttreatment. There were minimal side effects, no significant changes in safety parameters, and no serious adverse events. There was a 12.5% frequency of allergic rash in the CX516 group and 1 subject developed a substantial rash. There was also no significant improvement in memory, the primary outcome measure, or in secondary measures of language, attention/executive function, behavior, and overall functioning in CX516-treated subjects compared to placebo. This study did demonstrate that many outcome measures were reproducible in this test-retest setting for the FXS population, yet some were too difficult or variable. Adult subjects with FXS were able to complete an intensive clinical trial, and some valid outcome measures were identified for future FXS trial design. Problems with potency of CX516 in other studies have suggested dosing may have been inadequate for therapeutic effect and thus it remains unclear whether modulation of AMPA-mediated neurotransmission is a viable therapeutic strategy for the treatment of FXS.

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CX516 produced no significant improvement in the primary outcome measure or in secondary measures of language, attention/executive function, or behavior compared with placebo, possibly due to the potency or dosage used.
“No significant improvement in the primary outcome measure or in secondary measures of language, attention/executive function, or behavior was observed when compared with placebo, possibly due to the potency or dosage of CX516 used (105).”
From Fragile X syndrome: causes, diagnosis, mechanisms, and therapeutics (2012) · cites this paper as [105]

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Authors: Berry-Kravis, E., Krause, S. E., Block, S. S., Guter, S., Wuu, J., Leurgans, S., Decle, P., Potanos, K., Cook, E., Salt, J., Maino, D., Weinberg, D., Lara, R., Jardini, T., Cogswell, J., Johnson, S. A., & Hagerman, R.
Affiliations: Departments of Pediatrics, Neurological Sciences, Biochemistry, RUSH University Medical Center, Chicago, Illinois.
Krause Speech and Language Services, Chicago, Illinois.
Illinois College of Optometry (US)
Institute for Juvenile Research, University of Illinois at Chicago, Chicago, Illinois.
Rush University Medical Center (US)
MIND Institute and Department of Pediatrics, University of California at Davis, Davis, California.
University of Illinois Chicago (US)
University of California, Davis (US)
Cortex Pharmaceuticals (United States) (US)
ORCID: Block, Sandra S.
Wuu, Joanne
Leurgans, Sue
Cook, Edwin
Hagerman, Randi
Venue: Journal of Child and Adolescent Psychopharmacology
Publisher: SAGE Publications
Published: 2006-10
Volume: 16
Issue: 5
Pages: 525-540
ISSN: 1044-5463 (ISSN-L)
1557-8992
DOI: 10.1089/cap.2006.16.525
OpenAlex: W2040009554
Cited by: 155
References: 26
Citations by year: 2026: 2 · 2025: 5 · 2024: 6 · 2023: 3 · 2022: 4 · 2021: 4 · 2020: 7 · 2019: 4 · 2018: 6 · 2017: 18 · 2016: 5 · 2015: 13 · 2014: 8 · 2013: 13 · 2012: 9
FWCI: 5.30
Type: journal article
Language: en
Open access: closed
Licence: www.liebertpub.com/nv/resources-tools/text-and-data-mining-policy/121/ (tdm)
Locations: Journal of Child and Adolescent Psychopharmacology (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetics and Neurodevelopmental Disorders
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neuropharmacology Research
Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
Keywords: fragile X syndrome, ampakines, cognitive function, memory, behavioral effects, drug safety, adverse events, outcome measures, treatment efficacy
MeSH terms: Adolescent, Adult, Autistic Disorder, Child Behavior Disorders, Cognition Disorders, Drug Eruptions, Dioxoles, Dose-Response Relationship, Drug, Double-Blind Method, Female, Fragile X Syndrome, Humans, Male, Synaptic Transmission, Neuronal Plasticity, Neuropsychological Tests, Personality Assessment, Piperidines, Treatment Outcome, Long-Term Potentiation, Receptors, AMPA

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Effect of CX516, an AMPA-Modulating Compound, on Cognition and Behavior in Fragile X Syndrome: AControlled Trial

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