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

January 18, 2013 updated by: Supernus Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 32408
        • Florida Clinical Research Center
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Orlando, Florida, United States, 32806
        • CNS Healthcare
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • The Psychopharm Research Cntr - LSU Dept of Psychiatry
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Alliance Research Group
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment 1
Drug: SPN-810
capsule taken three times a day
Drug: SPN-810
capsule taken TID
Experimental: Treatment 2
Drug: SPN-810
capsule taken three times a day
Drug: SPN-810
capsule taken TID
Experimental: Treatment 3
Drug: SPN-810
capsule taken three times a day
Drug: SPN-810
capsule taken TID
Experimental: Treatment 4
Drug: SPN-810
capsule taken three times a day
Drug: SPN-810
capsule taken TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety scales (Simpson-Angus, Barnes Akathisia, AIMS)
Time Frame: weekly for duration of treatment
weekly for duration of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Nisonger Child Behavior Rating Form - TIQ
Time Frame: screening, then weekly and at final visit
screening, then weekly and at final visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supernus Pharmaceuticals, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 810P201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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