At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 25 enrolled
Drug / intervention
Paliperidone ERdrug
Likely dose
Paliperidone ER 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism
In Brief
A Phase 3 clinical trial evaluating Paliperidone ER for Autism. Completed, enrolled 25 participants across 1 site.
Detailed Summary
This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
CollaboratorsOrtho-McNeil Janssen Scientific Affairs, LLC
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartNov 2007
Primary CompletionSep 2010
TodayJul 2026
First PostedOct 26, 2007
Enrollment StartNov 1, 2007
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.7 years ago
Interventions
Paliperidone ERdrug
Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.