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NCT01911442 · ClinicalTrials.gov registry record · Phase 3
Lurasidone Pediatric Autism Study
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT01911442: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT01911442 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01911442, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.
Primary Outcome
The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness.
Interventions
- DRUG Placebo
- DRUG Lurasidone
- DRUG Lurasidone 20 mg daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01911442 record still lists
NCT01911442 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01911442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01911442 about?
NCT01911442 is a clinical study titled "Lurasidone Pediatric Autism Study". This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in ...
What is the current status of trial NCT01911442?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2013-08. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01911442?
The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG), Lurasidone 20 mg daily (DRUG).
Who is sponsoring clinical trial NCT01911442?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01911442's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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