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NCT03231800 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.

A Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
95
Enrollment target
8
Study locations

NCT03231800 is a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Sumitomo Pharma America. The registered enrollment target is 95 participants, below the 141-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (33% lower). The trial reports 8 study locations across 6 states.

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The verdict

NCT03231800, a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
95 participants
Enrollment target
8
Study locations

Study Summary

A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.

Interventions

  • DRUG Placebo
  • DRUG dasotraline

Study Locations (8)

Florida

  • Meridien Research - Bradenton
  • Meridien Research - Maitland
  • Qps-Mra, Llc - South Miami

California

  • Avida Inc - Newport Beach

Massachusetts

  • South Shore Psychiatric Services PC - Hingham

Nevada

  • Center for Psychiatry and Behavioral Medicine, Inc - Las Vegas

Texas

  • Bayou City Research, Ltd - Houston

Utah

  • Ericksen Reasearch and Development - Clinton

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2017-07-31
Est. Completion 2019-03-15
Phase Phase 3

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT03231800

The ClinicalTrials.gov registry entry for NCT03231800 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 141-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (33% lower). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03231800 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03231800 about?

NCT03231800 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.". A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.

What is the current status of trial NCT03231800?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2017-07-31. Estimated completion is 2019-03-15.

What conditions does trial NCT03231800 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD).

What interventions are being tested in trial NCT03231800?

The interventions under investigation include: Placebo (DRUG), dasotraline (DRUG).

Who is sponsoring clinical trial NCT03231800?

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

Where is trial NCT03231800 being conducted?

This trial has 8 study locations across California, Florida, Massachusetts, Nevada, Texas. 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

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