PHARM - A phase 4, randomized, double-blind, multicenter, parallel-group, active-controlled, forced-dose titration, safety and efficacy study of SPD48
Project Description:
A phase 4, randomized, double-blind, multicenter, parallel-group, active-controlled, forced-dose titration, safety and efficacy study of SPD489 compared with OROS-MPH with a placebo reference arm, in adolescents aged 13-17 years with ADHD
Objectives:
Primary:
The primary objective is to evaluate the efficacy of VYVANSE 70mg compared with CONCERTA 72mg in adolescents (13-17 years of age inclusive) with ADHD. The primary measure of efficacy will be the total score for the clinician-administered Attention deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV).
Key secondary:
To evaluate the efficacy of VYVANSE 70mg compared with CONCERTA 72mg, using a global clinical measure of improvement, the Clinical Global Impressions Global Improvement (CGI-I)
Additional secondary:
To evaluate the safety and tolerability of VYVANSE 70mg and CONCERTA 72mg based on the occurrence of treatment-emergent adverse events (TEAEs) and specific evaluation of blood pressure and pulse.
Rationale:
The VYVANSE clinical program has studied the efficacy, safety, and tolerability of VYVANSE as compared with placebo in treating core symptoms of ADHD in subjects aged 6-55 years. Similarly, long-acting preparations of stimulant medications such as methylphenidate (MPH) have been extensively studied in placebo-controlled clinical studies. However, no prospectively designed randomized controlled head to head comparison of the effects of these different classes of long-acting stimulant preparations on the core symptoms of ADHD has been conducted.
Keyword(s):
ADHD, vyvanse, concerta, adolescents
Core Function(s):
Performing Research or Evaluation
Area of Emphasis
Health-Related Activities
Target Audience:
Professionals and Para-Professionals, Family Members/Caregivers, Children/Adolescents with Disabilities/SHCN
Unserved or Under-served Populations:
Specific Groups
Primary Target Audience Geographic Descriptor:
National
COVID-19 Related Data:
N/A
