Open-Label, Extension Study to 810P202

Phase 2

Completed

• Conditions: Impulsive Aggression Comorbid With ADHD in Children
• Interventions: Drug: Molindone

• Registration Number: NCT01416064
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Study Start: 2011-09
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Disposition First Submitted: 2013-05-22
• Disposition First Submitted QC: 2013-05-22
• Disposition First Posted: 2013-06-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Successful completion of the 810P202 study.
2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
3. Weight of at least 20kg.
4. Able and willing to swallow tablets whole and not chewed, cut or crushed.
5. Written informed consent/assent obtained from the subject's parent or legally-authorized representative (LAR), and written informed assent obtained from the subject if required.

Exclusion Criteria

1. Body Mass Index (BMI) in 97th percentile or above.
2. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
4. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Molindone	Molindone	Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion.

Primary Outcome Measures

Name	Time	Method
Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD	over 6 months	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)

Secondary Outcome Measures

Name	Time	Method
Assess the efficacy of 810M	over 6 months	Secondary efficacy endpoints: Retrospective-Modified Overt Aggression Scale (R-MOAS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I), Swanson, Nolan and Pelman Rating Scale-Revised (SNAP-IV) ADHD scale scores