A study to assess SPD503 in children and adolescents with ADHD

• Research type

  Research Study

• Full title

  A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder

• IRAS ID

  57456

• Contact name

  Chris Steer

• Sponsor organisation

  Shire Pharmaceutical Development Ltd

• Eudract number

  2010-018579-12

• Research summary

  STUDY TO ASSESS THE EFFICACY AND SAFETY OF SPD503 COMPARED TO PLACEBO IN CHILDREN AND ADOLESCENTS WITH ADHD. Attention 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 non-stimulant 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. Non-stimulant medications such as STRATTERA© or SPD503 are considered an alternative option for treating ADHD. They provide a treatment option in those patients, who are not candidates for stimulant treatment. The product used in this study is SPD503, extended release guanfacine hydrochloride. Extended-release guanfacine hydrochloride 1, 2, 3, and 4mg (INTUNIV?½) was approved in the United States in September of 2009 for the treatment of ADHD in children and adolescents aged 6-17 years. This study is a randomised, double-blind, multicentre, parallel-group, placebo-controlled, dose-optimisation, efficacy and safety study, which includes an active reference arm (STRATTERA©). Children aged 6-12 years and adolescents aged 13-17 years diagnosed with ADHD will be randomised to receive SPD503, STRATTERA© or placebo. The study will consist of 5 periods: (1)Screening and washout, (2) dose optimisation period of 4 weeks for children aged 6-12 years and 7 weeks for adolescents aged 13-17 years, (3) dose maintenance period of 6 weeks, (4) two-week dose taper, and (5) one-week follow-up. Approximately 333 participants will be randomised into the study which will be conducted at approximately 50 sites in Europe, Canada and the US.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  10/S0501/52

• Date of REC Opinion

  26 Jan 2011

• REC opinion

  Further Information Favourable Opinion