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NCT00857220 · ClinicalTrials.gov registry record · Phase 3

Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia

A Phase 3 study of Insomnia and Attention Deficit Hyperactivity Disorder, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
304
Enrollment target
20
Study locations

NCT00857220 is a Phase 3 study of Insomnia and Attention Deficit Hyperactivity Disorder that has completed, run by Sumitomo Pharma America. The registered enrollment target is 304 participants, above the 168-participant average among 151 other Insomnia trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT00857220, a Phase 3 study of Insomnia and Attention Deficit Hyperactivity Disorder, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
304 participants
Enrollment target
20
Study locations

Study Summary

A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

Interventions

  • DRUG eszopiclone

Study Locations (20)

California

  • AV Institute, Inc. - Carson
  • Clinical Innovations, Inc. - Costa Mesa
  • Behavioral Research Specialists, LLC - Glendale
  • Sun Valley Research Center - Imperial
  • Excell Research, Inc. - Oceanside
  • North County Clinical Research (NCCR) - Oceanside
  • Pacific Clinical Research Medical Group - Orange
  • SDS Clinical Trials, Inc. - Orange
  • Clinical Innovations, Inc. - Riverside
  • Artemis Institute for Clinical Research - San Diego
  • Clinical Innovations - San Diego
  • Neuropsychiatric Research Center of Orange County - Santa Ana
  • Apex Research Institute - Santa Ana
  • Clinical Innovations, Inc. - Santa Ana
  • Elite Clinical Trials, Inc. - Wildomar

Florida

  • Sarkis Clinical Trials - Gainesville
  • MD Clinical - Hallandale

Arizona

  • REM Medical Clinical Research - Tucson

Arkansas

  • Clinical Study Centers, LLC - Little Rock

Colorado

  • Delta Waves, Inc. - Colorado Springs

Trial Details

FieldValue
Enrollment Target 304 participants
Start Date 2009-05
Est. Completion 2011-10
Phase Phase 3

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT00857220

The ClinicalTrials.gov registry entry for NCT00857220 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 168-participant average among 151 other Insomnia trials with a reported enrollment target (81% higher). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which eszopiclone is the first listed.

NCT00857220 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT00857220 about?

NCT00857220 is a clinical study titled "Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia". A multicenter study to evaluate the safety of eszopiclone 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 NCT00857220?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2009-05. Estimated completion is 2011-10.

What conditions does trial NCT00857220 study?

This clinical trial studies the following conditions: Insomnia, Attention Deficit Hyperactivity Disorder.

What interventions are being tested in trial NCT00857220?

The interventions under investigation include: eszopiclone (DRUG).

Who is sponsoring clinical trial NCT00857220?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00857220 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.