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NCT00856973 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 486
- Enrollment target
NCT00856973: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT00856973 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 486 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00856973, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 486 participants
- Enrollment target
Study Summary
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
Primary Outcome
A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as
Interventions
- DRUG Placebo
- DRUG eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00856973 record still lists
NCT00856973 is an interventional study that assigns participants to a tested intervention. The registered 486 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 (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00856973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00856973 about?
NCT00856973 is a clinical study titled "Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia". A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
What is the current status of trial NCT00856973?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 486 participants. The study started on 2009-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00856973?
The interventions under investigation include: Placebo (DRUG), eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00856973?
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 NCT00856973's enrollment target sits among peer trials
486 789th of 2000 higher than 1,211 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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