Phase 2
Completed N=222
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
Source: ClinicalTrials.gov NCT02633527 ↗Enrolled (actual)
222
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) — -10.5; -16.7; -18.4; -18.6 units on a scale — p=0.0899
Summary
This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) |
-10.5; -16.7; -18.4; -18.6; -19.0 | 0.0899 |
| SECONDARY Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale |
3.0; 2.6; 2.6; 2.2; 2.4 | 0.1305 |
| SECONDARY Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale |
-0.8; -1.4; -1.5; -1.6; -1.7 | 0.0708 |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
- CGI-S score of at least 4
- Weight of at least 20 kg.
- Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.
Exclusion Criteria
- Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
- Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
- Significant systemic disease.
- Evidence of suicidality within the six months before Screening or at Screening.
- BMI greater than 95th percentile for the appropriate age and gender.
- Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
- Substance or alcohol use during the last three months.
- Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
Data sourced from ClinicalTrials.gov (NCT02633527). 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. Informational only — not medical advice.