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:
Supernus Pharmaceuticals, Inc.
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
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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:
- 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 Criteria:
- 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.
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 May 16, 2013