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Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) / V. CRUTEL in Journal of Autism and Developmental Disorders, 51-8 (August 2021)
[article]
Titre : Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) Type de document : Texte imprimé et/ou numérique Auteurs : V. CRUTEL, Auteur ; E. LAMBERT, Auteur ; P. F. PENELAUD, Auteur ; C. ALBARRÁN SEVERO, Auteur ; J. FUENTES, Auteur ; A. ROSIER, Auteur ; A. HERVAS, Auteur ; S. MARRET, Auteur ; G. OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; S. KYAGA, Auteur ; S. GOUTTEFANGEAS, Auteur ; M. BERTRAND, Auteur ; D. RAVEL, Auteur ; B. FALISSARD, Auteur Article en page(s) : p.2959-2972 Langues : Anglais (eng) Mots-clés : Adolescent Autism Spectrum Disorder/drug therapy Bumetanide/administration & dosage/therapeutic use Child Child, Preschool Double-Blind Method Humans Male Research Design Social Behavior Treatment Outcome Autism spectrum disorder Bumetanide Pediatrics Randomized controlled trial for Actelion, Allergan, Almirall, Astellas, AstraZeneca, Bayer, Biotronik, BMS, Boehringer Ingelheim, Daiichi- Sankyo, Eli Lilly, Genzyme, Gilead, Grunenthal, GSK, HRA, Janssen, Lundbeck, MSD, Novartis, Otsuka, Pierre Fabre, Roche, Sanofi, Servier, Stallergene, UCB, ViiV. JF has received research support from Servier and AIMS-2-Trials project ID 777394. DR is an employee of Neurochlore. GO, SM, AR, AH, and MP report no conflict of interest. Index. décimale : PER Périodiques Résumé : There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD). We describe the design of two Phase III studies evaluating the efficacy/safety of bumetanide oral liquid formulation in ASD. These are international, multicenter, randomized, double-blind, placebo-controlled studies in children and adolescents with ASD aged 7 to 17 years (n?=?200; study 1), or younger children with ASD aged 2 to 6 years (n?=?200; study 2). The primary endpoint of each is change in Childhood Autism Rating Scale 2 total raw score after 6 months. These studies could contribute to the first pharmacological treatment to improve social reciprocity and limit repetitive and rigid behaviors in children and adolescents with ASD. En ligne : http://dx.doi.org/10.1007/s10803-020-04709-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=453
in Journal of Autism and Developmental Disorders > 51-8 (August 2021) . - p.2959-2972[article] Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) [Texte imprimé et/ou numérique] / V. CRUTEL, Auteur ; E. LAMBERT, Auteur ; P. F. PENELAUD, Auteur ; C. ALBARRÁN SEVERO, Auteur ; J. FUENTES, Auteur ; A. ROSIER, Auteur ; A. HERVAS, Auteur ; S. MARRET, Auteur ; G. OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; S. KYAGA, Auteur ; S. GOUTTEFANGEAS, Auteur ; M. BERTRAND, Auteur ; D. RAVEL, Auteur ; B. FALISSARD, Auteur . - p.2959-2972.
Langues : Anglais (eng)
in Journal of Autism and Developmental Disorders > 51-8 (August 2021) . - p.2959-2972
Mots-clés : Adolescent Autism Spectrum Disorder/drug therapy Bumetanide/administration & dosage/therapeutic use Child Child, Preschool Double-Blind Method Humans Male Research Design Social Behavior Treatment Outcome Autism spectrum disorder Bumetanide Pediatrics Randomized controlled trial for Actelion, Allergan, Almirall, Astellas, AstraZeneca, Bayer, Biotronik, BMS, Boehringer Ingelheim, Daiichi- Sankyo, Eli Lilly, Genzyme, Gilead, Grunenthal, GSK, HRA, Janssen, Lundbeck, MSD, Novartis, Otsuka, Pierre Fabre, Roche, Sanofi, Servier, Stallergene, UCB, ViiV. JF has received research support from Servier and AIMS-2-Trials project ID 777394. DR is an employee of Neurochlore. GO, SM, AR, AH, and MP report no conflict of interest. Index. décimale : PER Périodiques Résumé : There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD). We describe the design of two Phase III studies evaluating the efficacy/safety of bumetanide oral liquid formulation in ASD. These are international, multicenter, randomized, double-blind, placebo-controlled studies in children and adolescents with ASD aged 7 to 17 years (n?=?200; study 1), or younger children with ASD aged 2 to 6 years (n?=?200; study 2). The primary endpoint of each is change in Childhood Autism Rating Scale 2 total raw score after 6 months. These studies could contribute to the first pharmacological treatment to improve social reciprocity and limit repetitive and rigid behaviors in children and adolescents with ASD. En ligne : http://dx.doi.org/10.1007/s10803-020-04709-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=453 Effects of bumetanide on neurodevelopmental impairments in patients with tuberous sclerosis complex: an open-label pilot study / Dorinde M. VAN ANDEL in Molecular Autism, 11 (2020)
[article]
Titre : Effects of bumetanide on neurodevelopmental impairments in patients with tuberous sclerosis complex: an open-label pilot study Type de document : Texte imprimé et/ou numérique Auteurs : Dorinde M. VAN ANDEL, Auteur ; Jan J. SPRENGERS, Auteur ; Bob ORANJE, Auteur ; Floor E. SCHEEPERS, Auteur ; Floor E. JANSEN, Auteur ; Hilgo BRUINING, Auteur Article en page(s) : 30 p. Langues : Anglais (eng) Mots-clés : Bumetanide Erp Irritability NKCC1 antagonist Neurocognitive task Open-label Tand Tuberous sclerosis complex Index. décimale : PER Périodiques Résumé : BACKGROUND: Tuberous sclerosis complex (TSC) is an autosomal dominant disease that affects multiple organs including the brain. TSC is strongly associated with broad neurodevelopmental disorders, including autism spectrum disorder symptomatology. Preclinical TSC studies have indicated altered neuronal chloride homeostasis affecting the polarity of ?-aminobutyric acid (GABA) ergic transmission as a potential treatment target. Bumetanide, a selective NKCC1 chloride importer antagonist, may attenuate depolarizing GABA action, and in that way reduce disease burden. In this open-label pilot study, we tested the effect of bumetanide on a variety of neurophysiological, cognitive, and behavioral measures in children with TSC. METHODS: Participants were treated with bumetanide (2dd 0.5-1.0?mg) for 13?weeks in an open-label trial. The Aberrant Behavior Checklist-Irritability (ABC-I) subscale was chosen as the primary endpoint. Secondary endpoints included other behavioral questionnaires in addition to event-related potentials (ERP) and neuropsychological tests if tolerated. Additionally, the treatment effect on seizure frequency and quality of life was assessed. Endpoint data were collected at baseline, after 91?days of treatment and after a 28-day wash-out period. RESULTS: Fifteen patients (8-21-years old) with TSC were included of which 13 patients completed the study. Treatment was well-tolerated with only expected adverse events due to the diuretic effects of bumetanide. Irritable behavior (ABC-I) showed significant improvement after treatment in 11 out of 13 patients (t(12) = 4.41, p = .001, d = .773). A favorable effect was also found for social behavior (Social Responsiveness Scale) (t(11) = 4.01, p = .002, d = .549) and hyperactive behavior (ABC-hyperactivity subscale) (t(12) = 3.65, p = .003, d = .686). Moreover, patients rated their own health-related quality of life higher after treatment. At baseline, TSC patients showed several atypical ERPs versus typically developing peers of which prepulse inhibition was significantly decreased in the TSC group. Neuropsychological measurements showed no change and bumetanide had no effect on seizure frequency. LIMITATIONS: The sample size and open-label design of this pilot study warrant caution when interpreting outcome measures. CONCLUSIONS: Bumetanide treatment is a potential treatment to alleviate the behavioral burden and quality of life associated with TSC. More elaborate trials are needed to determine the application and effect size of bumetanide for the TSC population. Trial registration EU Clinical Trial Register, EudraCT 2016-002408-13 (www.clinicaltrialsregister.eu/ctr-search/trial/2016-002408-13/NL). Registered 25 July 2016. En ligne : http://dx.doi.org/10.1186/s13229-020-00335-4 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=427
in Molecular Autism > 11 (2020) . - 30 p.[article] Effects of bumetanide on neurodevelopmental impairments in patients with tuberous sclerosis complex: an open-label pilot study [Texte imprimé et/ou numérique] / Dorinde M. VAN ANDEL, Auteur ; Jan J. SPRENGERS, Auteur ; Bob ORANJE, Auteur ; Floor E. SCHEEPERS, Auteur ; Floor E. JANSEN, Auteur ; Hilgo BRUINING, Auteur . - 30 p.
Langues : Anglais (eng)
in Molecular Autism > 11 (2020) . - 30 p.
Mots-clés : Bumetanide Erp Irritability NKCC1 antagonist Neurocognitive task Open-label Tand Tuberous sclerosis complex Index. décimale : PER Périodiques Résumé : BACKGROUND: Tuberous sclerosis complex (TSC) is an autosomal dominant disease that affects multiple organs including the brain. TSC is strongly associated with broad neurodevelopmental disorders, including autism spectrum disorder symptomatology. Preclinical TSC studies have indicated altered neuronal chloride homeostasis affecting the polarity of ?-aminobutyric acid (GABA) ergic transmission as a potential treatment target. Bumetanide, a selective NKCC1 chloride importer antagonist, may attenuate depolarizing GABA action, and in that way reduce disease burden. In this open-label pilot study, we tested the effect of bumetanide on a variety of neurophysiological, cognitive, and behavioral measures in children with TSC. METHODS: Participants were treated with bumetanide (2dd 0.5-1.0?mg) for 13?weeks in an open-label trial. The Aberrant Behavior Checklist-Irritability (ABC-I) subscale was chosen as the primary endpoint. Secondary endpoints included other behavioral questionnaires in addition to event-related potentials (ERP) and neuropsychological tests if tolerated. Additionally, the treatment effect on seizure frequency and quality of life was assessed. Endpoint data were collected at baseline, after 91?days of treatment and after a 28-day wash-out period. RESULTS: Fifteen patients (8-21-years old) with TSC were included of which 13 patients completed the study. Treatment was well-tolerated with only expected adverse events due to the diuretic effects of bumetanide. Irritable behavior (ABC-I) showed significant improvement after treatment in 11 out of 13 patients (t(12) = 4.41, p = .001, d = .773). A favorable effect was also found for social behavior (Social Responsiveness Scale) (t(11) = 4.01, p = .002, d = .549) and hyperactive behavior (ABC-hyperactivity subscale) (t(12) = 3.65, p = .003, d = .686). Moreover, patients rated their own health-related quality of life higher after treatment. At baseline, TSC patients showed several atypical ERPs versus typically developing peers of which prepulse inhibition was significantly decreased in the TSC group. Neuropsychological measurements showed no change and bumetanide had no effect on seizure frequency. LIMITATIONS: The sample size and open-label design of this pilot study warrant caution when interpreting outcome measures. CONCLUSIONS: Bumetanide treatment is a potential treatment to alleviate the behavioral burden and quality of life associated with TSC. More elaborate trials are needed to determine the application and effect size of bumetanide for the TSC population. Trial registration EU Clinical Trial Register, EudraCT 2016-002408-13 (www.clinicaltrialsregister.eu/ctr-search/trial/2016-002408-13/NL). Registered 25 July 2016. En ligne : http://dx.doi.org/10.1186/s13229-020-00335-4 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=427 Improving emotional face perception in autism with diuretic bumetanide: A proof-of-concept behavioral and functional brain imaging pilot study / Nouchine HADJIKHANI in Autism, 19-2 (February 2015)
[article]
Titre : Improving emotional face perception in autism with diuretic bumetanide: A proof-of-concept behavioral and functional brain imaging pilot study Type de document : Texte imprimé et/ou numérique Auteurs : Nouchine HADJIKHANI, Auteur ; Nicole R. ZÜRCHER, Auteur ; Ophelie ROGIER, Auteur ; Torsten RUEST, Auteur ; Loyse HIPPOLYTE, Auteur ; Yehezkel BEN-ARI, Auteur ; Eric LEMONNIER, Auteur Article en page(s) : p.149-157 Langues : Anglais (eng) Mots-clés : Autism spectrum disorders bumetanide emotion face perception fMRI GABA treatment Index. décimale : PER Périodiques Résumé : Clinical observations have shown that GABA-acting benzodiazepines exert paradoxical excitatory effects in autism, suggesting elevated intracellular chloride (Cl–)i and excitatory action of GABA. In a previous double-blind randomized study, we have shown that the diuretic NKCC1 chloride importer antagonist bumetanide, that decreases (Cl–)i and reinforces GABAergic inhibition, reduces the severity of autism symptoms. Here, we report results from an open-label trial pilot study in which we used functional magnetic resonance imaging and neuropsychological testing to determine the effects of 10 months bumetanide treatment in adolescents and young adults with autism. We show that bumetanide treatment improves emotion recognition and enhances the activation of brain regions involved in social and emotional perception during the perception of emotional faces. The improvement of emotion processing by bumetanide reinforces the usefulness of bumetanide as a promising treatment to improve social interactions in autism. En ligne : http://dx.doi.org/10.1177/1362361313514141 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=256
in Autism > 19-2 (February 2015) . - p.149-157[article] Improving emotional face perception in autism with diuretic bumetanide: A proof-of-concept behavioral and functional brain imaging pilot study [Texte imprimé et/ou numérique] / Nouchine HADJIKHANI, Auteur ; Nicole R. ZÜRCHER, Auteur ; Ophelie ROGIER, Auteur ; Torsten RUEST, Auteur ; Loyse HIPPOLYTE, Auteur ; Yehezkel BEN-ARI, Auteur ; Eric LEMONNIER, Auteur . - p.149-157.
Langues : Anglais (eng)
in Autism > 19-2 (February 2015) . - p.149-157
Mots-clés : Autism spectrum disorders bumetanide emotion face perception fMRI GABA treatment Index. décimale : PER Périodiques Résumé : Clinical observations have shown that GABA-acting benzodiazepines exert paradoxical excitatory effects in autism, suggesting elevated intracellular chloride (Cl–)i and excitatory action of GABA. In a previous double-blind randomized study, we have shown that the diuretic NKCC1 chloride importer antagonist bumetanide, that decreases (Cl–)i and reinforces GABAergic inhibition, reduces the severity of autism symptoms. Here, we report results from an open-label trial pilot study in which we used functional magnetic resonance imaging and neuropsychological testing to determine the effects of 10 months bumetanide treatment in adolescents and young adults with autism. We show that bumetanide treatment improves emotion recognition and enhances the activation of brain regions involved in social and emotional perception during the perception of emotional faces. The improvement of emotion processing by bumetanide reinforces the usefulness of bumetanide as a promising treatment to improve social interactions in autism. En ligne : http://dx.doi.org/10.1177/1362361313514141 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=256 Traiter l'autisme ? / Yehezkel BEN-ARI
Titre : Traiter l'autisme ? : Au-delà des gènes et de la psychanalyse Type de document : Texte imprimé et/ou numérique Auteurs : Yehezkel BEN-ARI, Auteur ; Eric LEMONNIER, Auteur ; Nouchine HADJIKHANI, Auteur Editeur : Bruxelles [Belgique] : De Boeck Année de publication : 2015 Autre Editeur : Marseille [France] : Solal Importance : 82 p. Format : 16cm x 24cm x 0,6cm ISBN/ISSN/EAN : 978-2-35327-305-8 Note générale : Bibliogr. Langues : Français (fre) Mots-clés : Bumétanide Chlore Index. décimale : AUT-F AUT-F - L'Autisme - Soins Résumé : Malgré les dernières avancées scientifiques, les troubles du spectre autistique n’ont pas encore trouvé de traitement. Les approches purement psychothérapeutiques, psychiatriques ou génétiques mènent à une impasse parce qu’elles ignorent deux déclencheurs des TSA : les déviations neuronales dans les premiers mois de l’enfance, et les différentes étapes de la maturation cérébrale. Les auteurs de cet ouvrage n’excluent aucun facteur de risque de l’autisme et livrent les résultats prometteurs de leurs recherches. Ils proposent, en soutien aux prises en charge habituelles, l’utilisation innovante d’un diurétique normalement utilisé pour traiter l’hypertension et l’œdème cérébral. Ils ne prétendent pas guérir l’autisme, mais plaident pour un dépistage et une prise en charge précoces associés à un traitement systémique sans effets secondaires importants. [Résumé d'Auteur/Editeur] Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=250 Traiter l'autisme ? : Au-delà des gènes et de la psychanalyse [Texte imprimé et/ou numérique] / Yehezkel BEN-ARI, Auteur ; Eric LEMONNIER, Auteur ; Nouchine HADJIKHANI, Auteur . - Bruxelles [Belgique] : De Boeck : Marseille [France] : Solal, 2015 . - 82 p. ; 16cm x 24cm x 0,6cm.
ISBN : 978-2-35327-305-8
Bibliogr.
Langues : Français (fre)
Mots-clés : Bumétanide Chlore Index. décimale : AUT-F AUT-F - L'Autisme - Soins Résumé : Malgré les dernières avancées scientifiques, les troubles du spectre autistique n’ont pas encore trouvé de traitement. Les approches purement psychothérapeutiques, psychiatriques ou génétiques mènent à une impasse parce qu’elles ignorent deux déclencheurs des TSA : les déviations neuronales dans les premiers mois de l’enfance, et les différentes étapes de la maturation cérébrale. Les auteurs de cet ouvrage n’excluent aucun facteur de risque de l’autisme et livrent les résultats prometteurs de leurs recherches. Ils proposent, en soutien aux prises en charge habituelles, l’utilisation innovante d’un diurétique normalement utilisé pour traiter l’hypertension et l’œdème cérébral. Ils ne prétendent pas guérir l’autisme, mais plaident pour un dépistage et une prise en charge précoces associés à un traitement systémique sans effets secondaires importants. [Résumé d'Auteur/Editeur] Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=250 Exemplaires (3)
Code-barres Cote Support Localisation Section Disponibilité DOC0003045 AUT-F BEN Livre Centre d'Information et de Documentation du CRA Rhône-Alpes AUT - L'Autisme Disponible DOC0003046 AUT-F BEN Livre Centre d'Information et de Documentation du CRA Rhône-Alpes AUT - L'Autisme Disponible DOC0003047 AUT-F BEN Livre Centre d'Information et de Documentation du CRA Rhône-Alpes AUT - L'Autisme Disponible Les abonnés qui ont emprunté ce document ont également emprunté :
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