Status:
COMPLETED
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Attention Deficit Disorder With Hyperactivity
Conduct Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.
Detailed Description
This will be a randomized, multicenter, parallel group, dose-ranging safety and tolerability study in children with ADHD and persistent serious conduct problems. The target subjects are healthy male o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2009
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00626236
Start Date
October 21 2008
End Date
September 23 2009
Last Update
December 9 2025
Active Locations (9)
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1
Florida Clinical Research Center
Bradenton, Florida, United States, 32408
2
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
3
CNS Healthcare
Orlando, Florida, United States, 32806
4
Capstone Clinical Research
Libertyville, Illinois, United States, 60048