RBR-8cq282已完成未知

se of Gastrin-Releasing Peptide in Pediatric Subjects with diagnosis of Autism.Study of cross-over, randomized, placebo-controlled, proof of concept for the evaluation of safety, tolerability and efficacy

Programa de Pós-Graduação em Saúde da Criança e Adolescente - Universidade Federal do Rio Grande do Sul0 个研究点开始时间: 2015年9月8日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Autism Diagnostic according to DSM-5 criteria, as confirmed by the investigator's judgment; Age between 3 and 9 years; Normal Neuroimaging (computed tomography or magnetic resonance imaging of the skull); Normal Genetic research (karyotype for girls; karyotyping and Fragile X research for boys); Subjects of use of psychopharmacological treatment considered appropriate by the investigator on a stable dose for at least 4 weeks before inclusion, without adjustment of the dose throughout the study;

•History of diabetes mellitus; Secondary autism presence or diseases with features common to autism, as follows: diagnosis of fragile X syndrome, Rett syndrome, Angelman syndrome, Prader-Willi syndrome and Smith-Lemli-Opitz syndrome, Tuberous Sclerosis; Be carrier of any condition associated with increased acid secretion in the gastrointestinal system (gastritis, gastric ulcer, duodenal ulcer, reflux esophagitis); History of heart disease; Any guy whose basic medication require dose adjustment or interruption; Any condition that, in the opinion of the investigator, would put the security of the individual at risk after exposure to the test substance; Reside outside the city of Porto Alegre and the metropolitan area; Parents or guardians refuse to sign the free and informed consent.

发起方

Programa de Pós-Graduação em Saúde da Criança e Adolescente - Universidade Federal do Rio Grande do Sul