Significant reduction in ADHD-RS-5 total score from CFB to EOS1,2
Adolescents 12 to 17 years of age
Qelbree showed consistent improvement in ADHD symptom control of inattention, hyperactivity, and impulsivity as early as week 1.1,2
Qelbree delivers a significant improvement on the subscales of both inattention and hyperactivity/impulsivity.1
ADHD diagnosis based on ADHD-RS-5 screener and DSM-5 criteria
Phase III trials methodology1,2
All clinical trials were randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multicenter studies.
CFB in the ADHD-RS-5 total score at EOS, Qelbree treatment group.
Inclusion criteria to include: males and females; adolescents 12 to 17 years; ADHD diagnosis based on criteria in the DSM-5, confirmed with the MINI-KID; ADHD-RS-5 total score of ≥28; CGI-S ≥4.
Exclusion criteria to include: major psychiatric disorder (MDD history allowed); major neurobiological disorder; history of seizures; significant systemic disease; evidence of suicidality within prior 6 months before screening.
Secondary analysis is based on ITT population.2
Study P302 EOS=Week 6.1
Abbreviations: ADHD-RS-5, Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th ed; CFB, change from baseline; CGI-S, Clinical Global Impression–Severity of Illness; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, 5th ed; EOS, end of study; ITT, intention to treat; MDD, major depressive disorder; MINI-KID, Mini-International Neuropsychiatric Interview for Children and Adolescents.
Simple to start1,2
Study P302: Titration at 1 week1,2
Age group: 12 to 17 years of age
ITT population: N=301
Study medication: 200-mg or matching placebo
Proven efficacy in robust clinical trials1,2
Primary efficacy measure: CFB to EOS on the ADHD-RS-5 Total Score vs placebo (N=301)1,2
Study 302 results:
ADHD-RS-5 total score at EOS was significantly reduced with Qelbree vs placebo. The CFB in the ADHD-RS-5 total score (LS mean ± SE) was -16.0 ± 1.45 for Qelbree 200 mg/day, -16.5 ± 1.38 for Qelbree 400 mg/day, and -11.7 ± 1.37 for placebo.1
- Once-daily Qelbree delivers a significant improvement on the subscales of both inattention and hyperactivity/impulsivity in children and adolescents.1
- Once-daily Qelbree demonstrates proven safety and tolerability and low discontinuation rates due to AEs in children and adolescents.2
Abbreviations: ADHD-RS-5, Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th ed; AEs, adverse events; CFB, change from baseline; EOS, end of study.