A study to assess SPD489 in children & adolescents with ADHD

• Research type

  Research Study

• Full title

  A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel group Study to Compare the Time to Response to Lisdexamfetamine Dimesylate and Atomoxetine Hydrochloride in Children and Adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy.

• IRAS ID

  28179

• Eudract number

  2009-011745-94

• Research summary

  Study to assess the time to response to SPD489 compared to STRATTERA© in children and adolescents with ADHD This study is a Phase 3b, randomised, double-blind, multi-centre, parallel-group, active-controlled, dose-optimisation safety and efficacy study. Children and adolescents (6-17 years of age inclusive) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) who are judged by the Investigator to have had an inadequate response to Methylphenidate (MPH) therapy will be randomised to SPD489 or STRATTERA© (an approved non-stimulant therapy for treatment of ADHD in Europe) and treated for 6 weeks to evaluate safety and efficacy. STRATTERA© has been chosen as the comparator drug for this study following recent guidance from the National Institute for Health and Clinical Excellence (NICE) and European ADHD Guidelines MPH therapy is widely viewed as the reference standard for the treatment of ADHD but not all individuals respond adequately. Among the 30% - 40% of children who do not respond to MPH, many may respond to other stimulants, particularly those that provide a longer effective duration of efficacy. Shire Pharmaceutical Development Ltd, the funder of this clinical trial, developed SPD489 as a long acting, once-daily treatment for ADHD. The study will have four phases: (1) screening and washout; (2) baseline, (3) 6-week double-blind evaluation of SPD489 and STRATTERA©; and (4) safety follow-up phone call. Participants will be required to visit the sites up to 8 times over an 8-9 week period. Participants will undergo a number of assessments including electrocardiogram (ECG), clinical laboratory tests and vital signs. Participants will also be required to complete quality of life questionnaires to assess their current ADHD symptoms. The study will be conducted at approximately 45 sites in Europe and North America. Approximately 210 participants will be randomised in a 1:1 ratio (SPD489: STRATTERA©).

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  09/S0501/57

• Date of REC Opinion

  19 Oct 2009

• REC opinion

  Further Information Favourable Opinion