A study to assess long-term efficacy of SPD503 in ADHD in paediatrics
Research type
Research Study
Full title
A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised-withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 with Attention-deficit/Hyperactivity Disorder
IRAS ID
62736
Contact name
Valerie Harpin
Sponsor organisation
Shire Development Inc.
Eudract number
2009-018161-12
Clinicaltrials.gov Identifier
Research summary
STUDY TO EVALUATE THE LONG-TERM MAINTENANCE OF EFFICACY OF SPD503 IN CHILDREN AND ADOLESCENTS (6 - 17 YEARS) WITH ADHD WHO RESPOND TO AN INITIAL OPEN-LABEL, SHORT TERM TREATMENT WITH SPD503Attention deficit/hyperactivity disorder (ADHD) is one of the most commonly diagnosed psychiatric disorders in school-aged children. ADHD is associated with significant psychiatric morbidity and functional impairment, including disruptive behaviours and a loss in educational productivity. Current treatment of patients with ADHD is divided into two groups of medicines: stimulant and nonstimulant therapy. Stimulant medications are effective in some cases; however, they may cause side effects. There are also concerns about the potential for abuse and lack of efficacy in some children. Nonstimulant medications such as SPD503 are considered an alternative option for treating ADHD. They provide a treatment option in those patients, who are not candidates for stimulant treatment. Extended release guanfacine hydrochloride 1, 2, 3, and 4mg (INTUNIVâ„¢) was approved in the United States in September of 2009 for the treatment of ADHD in children and adolescents aged 6-17 years. The SPD503 clinical program has studied the efficacy, safety, and tolerability of this product in treating symptoms of ADHD in children and adolescents aged 6-17 through short-term, placebo-controlled studies and long-term, open-label studies. This study will more rigorously assess the long-term maintenance of efficacy using a placebo controlled, randomised-withdrawal design. Approximately 510 participants will be enrolled into this study in about 60 sites in Australia, Canada, Europe and the US. The study will consist of approximately 6 periods: (1) Screening and washout; (2) 7-week open-label optimisation; (3) 6-week open-label maintenance of optimised SPD503; (4) 26-week (6-month) double-blind, randomised withdrawal of SPD503; (5) 2-week post-treatment taper; and (6) 1-week safety follow-up. Participants will be required to visit the study centre up to 25 times over approximately a 47 week period.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
10/H1306/78
Date of REC Opinion
23 Dec 2010
REC opinion
Further Information Favourable Opinion