Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials)

Autor/inn/en	Crutel, Véronique; Lambert, Estelle; Penelaud, Pierre-François; Albarrán Severo, Cristina; Fuentes, Joaquin; Rosier, Antoine; Hervás, Amaia; Marret, Stéphane; Oliveira, Guiomar; Parellada, Mara; Kyaga, Simon; Gouttefangeas, Sylvie; Bertrand, Marianne; Ravel, Denis; Falissard, Bruno
Titel	Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials)
Quelle	In: Journal of Autism and Developmental Disorders, 51 (2021) 8, S.2959-2972 (14 Seiten) PDF als Volltext Verfügbarkeit
Zusatzinformation	ORCID (Fuentes, Joaquin)
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	0162-3257
DOI	10.1007/s10803-020-04709-8
Schlagwörter	Autism; Pervasive Developmental Disorders; Children; Adolescents; Drug Therapy; Intervention; Symptoms (Individual Disorders); Behavior Problems; Interpersonal Competence; Pharmacology + Suchen Sie Ihr Suchwort? Autismus; Child; Kind; Kinder; Adolescent; Adolescence; Adoleszenz; Jugend; Jugendalter; Jugendlicher; Psychiatrische Symptomatik; Interpersonale Kompetenz; Arzneikunde
Abstract	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. (As Provided).
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Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2024/1/01