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Open-Label, Extension Study to 810P202

NCT01416064 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2017-05-02

No results posted yet for this 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).

Conditions

  • Impulsive Aggression Comorbid With ADHD in Children

Interventions

DRUG

Molindone

The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion.

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-01-31
Completion
2013-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416064 on ClinicalTrials.gov