Shire 318 - Open Label Study to Provide Continued Access to SPD503

• Research type

  Research Study

• Full title

  A Phase 3, Open-label, Multicentre, study to Provide Access to Guanfacine Hydrochloride Extended Release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who Participated in Study SPD503-315 or SPD503-316

• IRAS ID

  95144

• Contact name

  Valerie Harpin

• Sponsor organisation

  Shire Pharmaceutical Development Ltd.

• Eudract number

  2011-004668-31

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Attention deficit/hyperactivity syndrome (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 loss in educational productivity. The symptoms and subsequent impairment associated with ADHD are increasingly being recognized as a lifetime disease. Current ADHD treatment is divided into two groups: 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. Nonstimulant medications such as SPD503 are considered an alternative option for treatment in those patients who are not candidates for stimulant treatment. Extended release guanfacine hydrochloride 1,2,3 and 4 mg (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. 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. Two, 2-year, open-label studies have confirmed the safety and on-going efficacy in this patient population. Study SPD503-318 has been designed to provide up to 2 years access to SPD503 for European subjects who participated in study SPD503-315 or SPD503-316. The study will consist of four (4) phases: (1) Screening/Washout, (2)a 102-week Treamtent Phase (Dose Optimisation and Maintenance Period), (3) a 2-week Dose Taper; and (4) Safety Follow-Up (visit 7 days after last dose). Approximately 249 European patients will be eligible for enrolment into this study based on the number of patients participating in the SPD503-315 and SPD503-316 studies. The estimated number of patients may change based on regulatory or statistical strategies that may impact the sample size.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  12/YH/0020

• Date of REC Opinion

  14 Mar 2012

• REC opinion

  Further Information Favourable Opinion