PHARM - A phase 4, randomized, double-blind, multicenter, parallel group, active-controlled, dose-optimization safety and efficacy study of SPD489 (Vy
Project Description:
A phase 4, randomized, double-blind, multicenter, parallel group, active-controlled, dose-optimization safety and efficacy study of SPD489 (Vyvanse) compared with OROS-MPH (Concerta) with a placebo reference arm, in adolescents aged 13-17 years
Objectives:
Primary:
The primary objective is to evaluate the efficacy of VYVANSE compared with CONCERTA 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 compared with CONCERTA, 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 and CONCERTA 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):
adolescent, ADHD, Vyvanse, Concerta
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
