Back to resultsOpen-Label, Extension Study to 810P202
Primary Purpose
Impulsive Aggression Comorbid With ADHD in Children
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Molindone
Sponsored by
About this trial
This is an interventional treatment trial for Impulsive Aggression Comorbid With ADHD in Children
Eligibility Criteria
Inclusion Criteria:
- Successful completion of the 810P202 study.
- Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
- Weight of at least 20kg.
- Able and willing to swallow tablets whole and not chewed, cut or crushed.
- 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:
- Body Mass Index (BMI) in 97th percentile or above.
- 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.
- Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Molindone
Arm Description
Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion.
Outcomes
Primary Outcome Measures
Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD
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
Assess the efficacy of 810M
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
Full Information
NCT ID
NCT01416064
First Posted
August 8, 2011
Last Updated
April 28, 2017
Sponsor
Supernus Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01416064
Brief Title
Open-Label, Extension Study to 810P202
Official Title
Open-Label Extension Study to Evaluate the Safety of Molindone Hydrochloride Extended-Release Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Aggression Comorbid With ADHD in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Molindone
Arm Type
Other
Arm Description
Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion.
Intervention Type
Drug
Intervention Name(s)
Molindone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD
Description
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)
Time Frame
over 6 months
Secondary Outcome Measure Information:
Title
Assess the efficacy of 810M
Description
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
Time Frame
over 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Successful completion of the 810P202 study.
Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
Weight of at least 20kg.
Able and willing to swallow tablets whole and not chewed, cut or crushed.
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:
Body Mass Index (BMI) in 97th percentile or above.
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.
Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.
Facility Information:
City
Dothan
State/Province
Alabama
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Wildomar
State/Province
California
Country
United States
City
Washington, D.C.
State/Province
District of Columbia
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Maitland
State/Province
Florida
Country
United States
City
North Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Libertyville
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Terre Haute
State/Province
Indiana
Country
United States
City
Owensboro
State/Province
Kentucky
Country
United States
City
Toms River
State/Province
New Jersey
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Bellevue
State/Province
Washington
Country
United States
City
Bothell
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label, Extension Study to 810P202
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