Phase 3
N=292
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
Attention Deficit Hyperactivity Disorder (ADHD)
Bottom Line
View on ClinicalTrials.gov: NCT02618434 ↗Enrolled (actual)
292
Serious AEs
1.7%
Results posted
Mar 2024
Primary outcome: Primary: Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary — -54.12; -51.64 Percent Change of IA behaviors — p=0.9383
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SPN-810 (18 mg) (Drug); SPN-810 (36 mg) (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary |
-54.12; -51.64 | 0.9383 |
| SECONDARY Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression - Severity Scale (CGI-S) |
-0.27; -0.45; -0.67; -0.96; -0.93; -1.06 | 0.0979 |
| SECONDARY Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated |
3.4; 3.3; 3.0; 2.7; 2.8; 2.5 | 0.0881 |
| SECONDARY Effect of SPN-810 on Impulsive Aggression Measured by Child Health Questionnaire Parent Form 28-item (CHQ-PF28) |
7.98; 10.86; 0.11; -2.29 | 0.3409 |
| SECONDARY Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF) |
-5.29; -7.38; -1.02; -1.05; -2.13; -2.42 | 0.5977 |
| SECONDARY Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Caregiver Rated |
3.1; 3.1; 2.9; 2.7; 2.7; 2.5 | 0.6171 |
| SECONDARY Effect of SPN-810 on Impulsive Aggression Measured by the Swanson, Nolan, Pelham Rating Scale- Revised (SNAP-IV) Rating Scale |
-0.33; -0.46; -0.33; -0.50; -0.50; -0.60 | 0.0416 sig |
| SECONDARY Effect of SPN-810 on Impulsive Aggression Measured by the Percentage of Responders |
73.9; 75.0; 54.3; 51.4 | 0.8525 |
Summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.
Eligibility Criteria
Inclusion Criteria
- Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.
- Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.
Exclusion Criteria
- Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
- Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis.
- Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.
Data sourced from ClinicalTrials.gov (NCT02618434). 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.