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NCT01416064 · ClinicalTrials.gov registry record · Phase 2

Open-Label, Extension Study to 810P202

A Phase 2 study of Impulsive Aggression Comorbid With ADHD in Children, sponsored by Supernus Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
78
Enrollment target
20
Study locations

NCT01416064 is a Phase 2 study of Impulsive Aggression Comorbid With ADHD in Children that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 78 participants. The trial reports 20 study locations across 10 states.

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The verdict

NCT01416064, a Phase 2 study of Impulsive Aggression Comorbid With ADHD in Children, has completed, sponsored by Supernus Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
78 participants
Enrollment target
20
Study locations

Study Summary

Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).

Interventions

  • DRUG Molindone

Study Locations (20)

Florida

  • - Bradenton
  • - Gainesville
  • - Hialeah
  • - Jacksonville
  • - Maitland
  • - North Miami
  • - Orlando
  • - Tampa

California

  • - Los Angeles
  • - Santa Ana
  • - Wildomar

Indiana

  • - Indianapolis
  • - Terre Haute

Alabama

  • - Dothan

District of Columbia

  • - Washington D.C.

Georgia

  • - Atlanta

Illinois

  • - Libertyville

Kentucky

  • - Owensboro

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2011-09
Est. Completion 2013-02
Phase Phase 2

Sponsor

Supernus Pharmaceuticals

57 total trials

What the Registry Record Tells You About NCT01416064

The ClinicalTrials.gov registry entry for NCT01416064 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Supernus Pharmaceuticals, which has 57 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Impulsive Aggression Comorbid With ADHD in Children appearing as the primary indexed condition, and to 1 intervention - of which Molindone is the first listed.

NCT01416064 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Indiana.

Frequently Asked Questions

What is clinical trial NCT01416064 about?

NCT01416064 is a clinical study titled "Open-Label, Extension Study to 810P202". Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).

What is the current status of trial NCT01416064?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2011-09. Estimated completion is 2013-02.

What conditions does trial NCT01416064 study?

This clinical trial studies the following conditions: Impulsive Aggression Comorbid With ADHD in Children.

What interventions are being tested in trial NCT01416064?

The interventions under investigation include: Molindone (DRUG).

Who is sponsoring clinical trial NCT01416064?

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

Where is trial NCT01416064 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.