Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02618408 · ClinicalTrials.gov registry record · Phase 3

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)

A Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Supernus Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
333
Enrollment target
20
Study locations

NCT02618408 is a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 333 participants, above the 125-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (166% higher). The trial reports 20 study locations across 12 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02618408, a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Supernus Pharmaceuticals.

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

Study Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 426 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.

Conditions Studied

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

  • DRUG Placebo
  • DRUG SPN-810 (18 mg)
  • DRUG SPN-810 (36 mg)

Study Locations (20)

Florida

  • Meridien Research at Florida Clinical Research Center - Bradenton
  • Sarkis Clinical Trials - Gainesville
  • Florida Clinical Research Center, LLC. - Maitland
  • CNS Healthcare of Orlando - Orlando

California

  • ProScience - Culver City
  • Behavioral Research Specialists - Glendale
  • Neuropsychiatric Research Center of Orange County - Orange

Illinois

  • American Medical Research - Chicago
  • Capstone Clinical Research - Libertyville

Oklahoma

  • Oklahoma Clinical Research Center - Oklahoma City
  • Paradigm Research Professionals - Oklahoma City

Tennessee

  • CNS Healthcare - Memphis
  • Research Strategies of Memphis, LLC - Memphis

Arkansas

  • Woodland Research Northwest - Rogers

Kansas

  • Psychiatric Associates - Overland Park

Maryland

  • Hugo W Moser Research Institute at Kennedy Krieger - Baltimore

Trial Details

FieldValue
Enrollment Target 333 participants
Start Date 2016-01-25
Est. Completion 2019-10-24
Phase Phase 3

Sponsor

Supernus Pharmaceuticals

57 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02618408

The ClinicalTrials.gov registry entry for NCT02618408 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 125-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (166% higher). The listed sponsor is Supernus Pharmaceuticals, which has 57 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 3 interventions - of which Placebo is the first listed.

NCT02618408 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT02618408 about?

NCT02618408 is a clinical study titled "Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)". The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 426 subjects aged 6 to 12 years with...

What is the current status of trial NCT02618408?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 333 participants. The study started on 2016-01-25. Estimated completion is 2019-10-24.

What conditions does trial NCT02618408 study?

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

What interventions are being tested in trial NCT02618408?

The interventions under investigation include: Placebo (DRUG), SPN-810 (18 mg) (DRUG), SPN-810 (36 mg) (DRUG).

Who is sponsoring clinical trial NCT02618408?

This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02618408 being conducted?

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

Learn More About Clinical Trials

Similar trials for Attention Deficit Hyperactivity Disorder (ADHD)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Attention Deficit Hyperactivity Disorder (ADHD)

All registered trials for this condition

Arkansas

All trials with a study site in Arkansas

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.