[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 |
| Auteurs : |
Véronique CRUTEL, Auteur ; Estelle LAMBERT, Auteur ; Pierre-François PÉNÉLAUD, Auteur ; Cristina ALBARRÁN SEVERO, Auteur ; Joaquin FUENTES, Auteur ; Antoine ROSIER, Auteur ; Amaia HERVAS, Auteur ; Stéphane MARRET, Auteur ; Guiomar OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; Simon KYAGA, Auteur ; Sylvie GOUTTEFANGEAS, Auteur ; Marianne BERTRAND, Auteur ; Denis RAVEL, Auteur ; Bruno 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] / Véronique CRUTEL, Auteur ; Estelle LAMBERT, Auteur ; Pierre-François PÉNÉLAUD, Auteur ; Cristina ALBARRÁN SEVERO, Auteur ; Joaquin FUENTES, Auteur ; Antoine ROSIER, Auteur ; Amaia HERVAS, Auteur ; Stéphane MARRET, Auteur ; Guiomar OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; Simon KYAGA, Auteur ; Sylvie GOUTTEFANGEAS, Auteur ; Marianne BERTRAND, Auteur ; Denis RAVEL, Auteur ; Bruno 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 |
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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) in Journal of Autism and Developmental Disorders, 51-8 (August 2021)
