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

Phase 2

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity; Conduct Disorder
• Interventions: Drug: SPN-810

• Registration Number: NCT00626236
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Study Start: 2008-09
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-18
• Disposition First Submitted QC: 2013-01-18
• Last Update Submitted: 2013-01-18
• Disposition First Posted: 2013-01-28
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 1	SPN-810	-
Treatment 2	SPN-810	-
Treatment 3	SPN-810	-
Treatment 4	SPN-810	-

Primary Outcome Measures

Name	Time	Method
safety scales (Simpson-Angus, Barnes Akathisia, AIMS)	weekly for duration of treatment

Secondary Outcome Measures

Name	Time	Method
Nisonger Child Behavior Rating Form - TIQ	screening, then weekly and at final visit

Trial Locations

Locations (9)

Florida Clinical Research Center; 🇺🇸 Bradenton, Florida, United States

Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States

CNS Healthcare; 🇺🇸 Orlando, Florida, United States

Capstone Clinical Research; 🇺🇸 Libertyville, Illinois, United States

Northwest Clinical Trials; 🇺🇸 Bellevue, Washington, United States

The Psychopharm Research Cntr - LSU Dept of Psychiatry; 🇺🇸 Shreveport, Louisiana, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Memphis, Tennessee, United States

Alliance Research Group; 🇺🇸 Richmond, Virginia, United States

IPS Research; 🇺🇸 Oklahoma City, Oklahoma, United States