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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00549562
The ClinicalTrials.gov registry entry for NCT00549562 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 104 other Autism trials with a reported enrollment target (86% lower). The listed sponsor is Indiana University School of Medicine, which has 16 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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