Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00626236
First received: February 20, 2008
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Conduct Disorder
Drug: SPN-810
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • safety scales (Simpson-Angus, Barnes Akathisia, AIMS) [ Time Frame: weekly for duration of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Nisonger Child Behavior Rating Form - TIQ [ Time Frame: screening, then weekly and at final visit ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1 Drug: SPN-810
capsule taken three times a day
Experimental: Treatment 2 Drug: SPN-810
capsule taken TID
Experimental: Treatment 3 Drug: SPN-810
capsule taken TID
Experimental: Treatment 4 Drug: SPN-810
capsule taken TID

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy pediatric male or female subjects, age 6 to 12 years.
  2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
  3. 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.
  4. IQ greater than 71.

Exclusion Criteria:

  1. Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified.
  2. Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder.
  3. Any other anxiety disorder as primary diagnosis.
  4. Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline.
  5. Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626236

Locations
United States, Florida
Florida Clinical Research Center
Bradenton, Florida, United States, 32408
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
CNS Healthcare
Orlando, Florida, United States, 32806
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
United States, Louisiana
The Psychopharm Research Cntr - LSU Dept of Psychiatry
Shreveport, Louisiana, United States, 71103
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Virginia
Alliance Research Group
Richmond, Virginia, United States, 23229
United States, Washington
Northwest Clinical Trials
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Investigators
Principal Investigator: Robert Findling, MD University Hospitals Case Medical Center/Case Western Reserve University
  More Information

No publications provided by Supernus Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00626236     History of Changes
Other Study ID Numbers: 810P201
Study First Received: February 20, 2008
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Supernus Pharmaceuticals, Inc.:
ADHD and conduct problems

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014