A 2-year study of SPD489 in children & adolescents with ADHD

• Research type

  Research Study

• Full title

  A Phase 4, Open-label, Multicentre, 2-Year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)

• IRAS ID

  68976

• Contact name

  David Coghill

• Sponsor organisation

  Shire Development Inc.

• Eudract number

  2010-020951-30

• Research summary

  A Phase 4, Open-label, Multicentre, 2-Year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD). ADHD is the most common neuro-developmental disorder of childhood affecting 2-18% of school-age children. The treatment of ADHD in some children covers an important time in growth, physical, sexual, and cognitive (mental process of gaining knowledge) development. As such, further research into the concept of lifetime treatment with ADHD medications, in particular effects on growth, development, and neurocognition in addition to long-term safety is required. The study sponsor is Shire Pharmaceutical Development Ltd. The study will assess the long-term safety of SPD489, taken as a daily morning dose in the treatment of children and adolescents (6-17 years) with moderately to severely symptomatic ADHD. This is the first opportunity to collect data on endpoints like sexual development and cognition. The study will also serve to provide long-term safety data, since prior exposure has been limited to 1 year of treatment. Collection of this long-term data represents an important opportunity to better characterise the safety, effectiveness and tolerability of SPD489. SPD489 is provided as capsules containing doses 30, 50 and 70mg. The amount each participant takes will be determined during their first 4 weeks where the dose is increased until the optimal dose of SPD489 is reached. This will vary for each participant. Following titration to an optimal dose of SPD489, participants will continue daily morning treatment with SPD489 for 100 weeks. The study will be conducted at approximately 60 sites in Europe and up to 5 sites in the US and will enroll 300 participants. 50% of these participants will have taken part in a previous study of the Investigational Drug SPD489 (SPD489-317, SPD489-325, or SPD489-326). The other 50% will be participants who are new to treatment with SPD489.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  10/S0501/68

• Date of REC Opinion

  3 Mar 2011

• REC opinion

  Further Information Favourable Opinion