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

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 123-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (171% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the Baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 6, inclusive) and baseline period (Day ≤1), respectively. The IA behavior freq

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
Supernus Pharmaceuticals

57 total trials

What the finished NCT02618408 record still lists

NCT02618408 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, above the 123-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (171% higher).

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 names 20 study sites across 12 states, led by 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.

Where NCT02618408's enrollment target sits among peer trials

333 1st of 18 higher than 18 of 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder (ADHD) 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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Related registry views

Source: ClinicalTrials.gov NCT02618408, the US trial registry maintained by the National Library of Medicine. NCT02618408 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.