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NCT00549562 · ClinicalTrials.gov registry record · Phase 3
Study of Paliperidone ER in Adolescents and Young Adults With Autism
A Phase 3 study of Autism, sponsored by Indiana University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00549562: Completed Phase 3 study of Autism, sponsored by Indiana University School of Medicine.
NCT00549562 is a Phase 3 study of Autism that has completed, run by Indiana University School of Medicine. The registered enrollment target is 25 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00549562, a Phase 3 study of Autism, has completed, sponsored by Indiana University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point.
Conditions Studied
Interventions
- DRUG Paliperidone ER
Study Locations (1)
Indiana
- Riley Child & Adolescent Psychiatry Clinic- Riley Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT00549562 record still lists
NCT00549562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 1 intervention - of which Paliperidone ER is the first listed.
NCT00549562 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT00549562 about?
NCT00549562 is a clinical study titled "Study of Paliperidone ER in Adolescents and Young Adults With Autism". 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 yo...
What is the current status of trial NCT00549562?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2007-11. Estimated completion is 2010-09.
What conditions does trial NCT00549562 study?
This clinical trial studies the following conditions: Autism.
What interventions are being tested in trial NCT00549562?
The interventions under investigation include: Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT00549562?
This trial is sponsored by Indiana University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00549562 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00549562's enrollment target sits among peer trials
25 82nd of 104 higher than 20 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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