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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00626236
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Conduct Disorder Drug: SPN-810 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. safety scales (Simpson-Angus, Barnes Akathisia, AIMS) [ Time Frame: weekly for duration of treatment ]

Secondary Outcome Measures :
  1. Nisonger Child Behavior Rating Form - TIQ [ Time Frame: screening, then weekly and at final visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00626236

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.
Principal Investigator: Robert Findling, MD University Hospitals Case Medical Center/Case Western Reserve University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Supernus Pharmaceuticals, Inc. Identifier: NCT00626236     History of Changes
Other Study ID Numbers: 810P201
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms