Back to resultsPhase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
Primary Purpose
Attention Deficit Disorder With Hyperactivity, Conduct Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPN-810
SPN-810
SPN-810
SPN-810
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD and conduct problems
Eligibility Criteria
Inclusion Criteria:
- Healthy pediatric male or female subjects, age 6 to 12 years.
- Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
- NCBRF-TIQ disruptive behavior disorder subscale 27 or greater at baseline; AND a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people.
- IQ greater than 71.
Exclusion Criteria:
- Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified.
- Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder.
- Any other anxiety disorder as primary diagnosis.
- Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline.
- Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.
Sites / Locations
- Florida Clinical Research Center
- Sarkis Clinical Trials
- CNS Healthcare
- Capstone Clinical Research
- The Psychopharm Research Cntr - LSU Dept of Psychiatry
- IPS Research
- Clinical Neuroscience Solutions, Inc.
- Alliance Research Group
- Northwest Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment 1
Treatment 2
Treatment 3
Treatment 4
Arm Description
Outcomes
Primary Outcome Measures
safety scales (Simpson-Angus, Barnes Akathisia, AIMS)
Secondary Outcome Measures
Nisonger Child Behavior Rating Form - TIQ
Full Information
NCT ID
NCT00626236
First Posted
February 20, 2008
Last Updated
January 18, 2013
Sponsor
Supernus Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00626236
Brief Title
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
Official Title
A Randomized, Multicenter, Parallel Group, Dose-Ranging Study to Evaluate the Safety and Tolerability of SPN-810 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Persistent Serious Conduct Problems
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is hypothesized that, when given at the lowest effective dose, the favorable side effect profile combined with it's lower propensity for weight gain would make SPN-810 a candidate for treatment of persistent serious conduct problems in pediatric subjects with ADHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Conduct Disorder
Keywords
ADHD and conduct problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment 1
Arm Type
Experimental
Arm Title
Treatment 2
Arm Type
Experimental
Arm Title
Treatment 3
Arm Type
Experimental
Arm Title
Treatment 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPN-810
Intervention Description
capsule taken three times a day
Intervention Type
Drug
Intervention Name(s)
SPN-810
Intervention Description
capsule taken TID
Intervention Type
Drug
Intervention Name(s)
SPN-810
Intervention Description
capsule taken TID
Intervention Type
Drug
Intervention Name(s)
SPN-810
Intervention Description
capsule taken TID
Primary Outcome Measure Information:
Title
safety scales (Simpson-Angus, Barnes Akathisia, AIMS)
Time Frame
weekly for duration of treatment
Secondary Outcome Measure Information:
Title
Nisonger Child Behavior Rating Form - TIQ
Time Frame
screening, then weekly and at final visit
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:
Healthy pediatric male or female subjects, age 6 to 12 years.
Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
NCBRF-TIQ disruptive behavior disorder subscale 27 or greater at baseline; AND a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people.
IQ greater than 71.
Exclusion Criteria:
Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified.
Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder.
Any other anxiety disorder as primary diagnosis.
Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline.
Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Findling, MD
Organizational Affiliation
University Hospitals Case Medical Center/Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Clinical Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
32408
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
The Psychopharm Research Cntr - LSU Dept of Psychiatry
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Alliance Research Group
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Northwest Clinical Trials
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22372512
Citation
Stocks JD, Taneja BK, Baroldi P, Findling RL. A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems. J Child Adolesc Psychopharmacol. 2012 Apr;22(2):102-11. doi: 10.1089/cap.2011.0087. Epub 2012 Feb 28.
Results Reference
derived
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Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
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