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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: Completed Phase 2 study of Impulsive Aggression Comorbid With ADHD in Children, sponsored by Supernus Pharmaceuticals.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Safety Assessments include: Adverse Events, clinical lab tests, vital signs, physical examinations, ECGs, Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS) and Columbia Suicise Severity Rating Scale (C-SSRS)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
What the finished NCT01416064 record still lists
NCT01416064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01416064's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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