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 AreaNervous SystemProduct ClassPsycholepticsPharmacological SubgroupAntipsychoticsChemical SubgroupOther AntipsychoticsCondition StudiedAutistic Disorder
Sponsor Protocol NumberRIS-AUT-JPN-01Enrollment39Data PartnerJohnson & Johnson% Female23.1%Mean/Median Age (Years)8.0% WhiteN/A

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

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