Study Phase 3

A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder

Trial Information

Generic NameRisperidoneProduct NameRISPERDAL®Therapeutic AreaBehaviors and Mental DisordersEnrollment39% Female23.1%% WhiteN/A
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRIS-AUT-JPN-01Data PartnerJohnson & JohnsonCondition StudiedAutistic DisorderMean/Median Age (Years)8

Supporting Documentation

  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available
Additional Information

Please note: individual participant-level data are not available for this trial. Only the protocol with amendments, statistical analysis report, and clinical study report are available.

Approved Data Requests Associated with this Trial

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.