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Guanfacine in the treatment of hyperactivity and implusiveness in children and adolescents with pervasive development disorders
This application is a request for transfer of this protocol from paper IRB to e-irb submission review:
Previous Application Number (paper based submission): 01-04-06-04
Protocol Title: Guanfacine in the Treatment of Hyperactivity and Impulsiveness in Children and Adolescents with Pervasive Developmental Disorders
This trial has ended. During the period since the last renewal (expiration 1/26/10), no children have been enrolled or participated in the study. No more subjects will be enrolled. We request that this protocol remain open until data analyses have been completed.
The original study evaluated the efficacy and safety of guanfacine for treating hyperactivity, impulsiveness, and distractibility in 25 (permission for 60 subjects was requested) children and adolescents (aged 4.5 - 14 years) with Pervasive Developmental Disorder. Five sites (KKI, OSU, IU, Yale, and UCLA) participated in the trial. 8 children were enrolled at the KKI site.
Please note: At KKI, the methylphenidate and guanfacine arms of protocol were submitted and approved as 2 separate protocol applications.