Phase 2
N=78
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
Attention Deficit Disorder With Hyperactivity · Conduct Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00626236 ↗Enrolled (actual)
78
Serious AEs
2.6%
Results posted
Sep 2025
Primary outcome: Primary: The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score — 20.4; 25.7; 26.0; 26.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPN-810 (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score |
20.4; 25.7; 26.0; 26.0; -0.6; -3.3 | — |
| SECONDARY The Changes From Baseline in the CGI-S |
4.35; 4.74; 4.63; 4.70; -0.20; -0.26 | — |
| SECONDARY Clinical Global Impression - Improvement Scale (CGI-I) |
0.00; 0.00; 0.00; 0.00; 0.00; -0.41 | — |
| SECONDARY SNAP-IV ADHD Inattention |
18.20; 20.42; 20.00; 21.05; -1.55; -1.74 | — |
| SECONDARY SNAP-IV Subscales ADHD Hyperactivity/Impulsivity |
19.60; 21.74; 19.11; 20.95; -0.90; -1.47 | — |
| SECONDARY SNAP-IV Subscales - ADHD Combined |
37.80; 42.16; 39.11; 42.00; -2.45; -3.21 | — |
Summary
The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00626236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.