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A Phase III Study of Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents Aged Between 7 and 17 Years with Autism Spectrum Disorder (SIGN 1 Trial): Participant Baseline Characteristics.

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Title: A Phase III Study of Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents Aged Between 7 and 17 Years with Autism Spectrum Disorder (SIGN 1 Trial): Participant Baseline Characteristics.
Authors: Georgoula, Christina (AUTHOR), Ferrin, Maite (AUTHOR), Pietraszczyk-Kedziora, Bozena (AUTHOR), Hervas, Amaia (AUTHOR), Marret, Stéphane (AUTHOR), Oliveira, Guiomar (AUTHOR), Rosier, Antoine (AUTHOR), Crutel, Véronique (AUTHOR), Besse, Emmanuelle (AUTHOR), Severo, Cristina Albarrán (AUTHOR), Ravel, Denis (AUTHOR), Fuentes, Joaquin (AUTHOR)
Source: Child Psychiatry & Human Development. Oct2023, Vol. 54 Issue 5, p1360-1372. 13p. 1 Diagram, 7 Charts, 1 Graph.
Subjects: Autism spectrum disorders, Children with autism spectrum disorders, Bumetanide, Autistic children, Autism in children
Abstract: The efficacy of bumetanide (oral liquid formulation 0.5 mg bid) as a treatment for the core symptoms of autism spectrum disorders in children and adolescents aged 7–17 years is being investigated in an international, randomised, double-blind, placebo-controlled phase III study. The primary endpoint is the change in Childhood Autism Rating Scale 2 (CARS2) total raw score after 6 months of treatment. At baseline, the 211 participants analysed are broadly representative of autistic subjects in this age range: mean (SD) age, 10.4 (3.0) years; 82.5% male; 47.7% with intelligence quotient ≥ 70. Mean CARS2 score was 40.1 (4.9) and mean Social Responsiveness Scale score was 116.7 (23.4). Final study results will provide data on efficacy and safety of bumetanide in autistic children and adolescents. [ABSTRACT FROM AUTHOR]
Copyright of Child Psychiatry & Human Development is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: A Phase III Study of Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents Aged Between 7 and 17 Years with Autism Spectrum Disorder (SIGN 1 Trial): Participant Baseline Characteristics.
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  Data: <searchLink fieldCode="JN" term="%22Child+Psychiatry+%26+Human+Development%22">Child Psychiatry & Human Development</searchLink>. Oct2023, Vol. 54 Issue 5, p1360-1372. 13p. 1 Diagram, 7 Charts, 1 Graph.
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  Data: <searchLink fieldCode="DE" term="%22Autism+spectrum+disorders%22">Autism spectrum disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Children+with+autism+spectrum+disorders%22">Children with autism spectrum disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Bumetanide%22">Bumetanide</searchLink><br /><searchLink fieldCode="DE" term="%22Autistic+children%22">Autistic children</searchLink><br /><searchLink fieldCode="DE" term="%22Autism+in+children%22">Autism in children</searchLink>
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  Data: The efficacy of bumetanide (oral liquid formulation 0.5 mg bid) as a treatment for the core symptoms of autism spectrum disorders in children and adolescents aged 7–17 years is being investigated in an international, randomised, double-blind, placebo-controlled phase III study. The primary endpoint is the change in Childhood Autism Rating Scale 2 (CARS2) total raw score after 6 months of treatment. At baseline, the 211 participants analysed are broadly representative of autistic subjects in this age range: mean (SD) age, 10.4 (3.0) years; 82.5% male; 47.7% with intelligence quotient ≥ 70. Mean CARS2 score was 40.1 (4.9) and mean Social Responsiveness Scale score was 116.7 (23.4). Final study results will provide data on efficacy and safety of bumetanide in autistic children and adolescents. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Child Psychiatry & Human Development is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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