SPD503-401 League
Research type
Research Study
Full title
A Phase 4, Multicenter, 2-part Study Composed of a 1-Year Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride\nProlonged-release (SPD503) in Children and Adolescents aged 6 to 17 Years\nwith Attention-deficit/Hyperactivity Disorder
IRAS ID
263131
Contact name
Dr Inyang Takon
Contact email
Sponsor organisation
Shire Development LLC
Eudract number
2018-000821-29
Clinicaltrials.gov Identifier
63,551, IND Number
Duration of Study in the UK
4 years, 10 months, 29 days
Research summary
Approximately 288 children and adolescents aged 6 to 17 years inclusive diagnosed with attention-deficit/hyperactivity disorder (ADHD) in approximately 65 sites in the European Union will take part in this study.\n\nThe study medications used in this study are guanfacine hydrochloride (SPD503) referred to as the “study drug’, atomoxetine, and a placebo. Guanfacine and atomoxetine are already authorised to treat participants with ADHD in some countries. A placebo is a look-alike capsule or tablet that has no active drug in it.\n\nThe purpose of this study is to see if SPD503 will be safe and effective as treatment for paediatric participants with ADHD when used for a longer period of time.\n\nThis study will be conducted in 2 parts: Study Part A and Study Part B. \n\nThe Study Part A is double-blinded which means that participants and study doctors will not know what treatment the participants will receive. They will be enrolled into the study into one of the following three treatment groups by randomisation (means that they will receive the allocated treatment by chance):\n\n- Group 1 (SPD503 treatment arm): will receive SPD503 tablets and placebo capsules. \n- Group 2 (Atomoxetine treatment arm): will received atomoxetine capsules and placebo tablets. \n- Group 3 (Placebo treatment arm): will receive placebo tablets and placebo capsules.\n\nAt the end of the first 18 weeks, participants in the placebo treatment arm will roll-over to Study Part B for an additional 52 weeks of treatment with SPD503 alone while participants in the other two arms will continue in Study Part A for the remainder of the 52 weeks. \n\nAt the end of 52 weeks, all participants will roll-over into Study Part B which will consist of an additional 1 year of treatment with the study drug (SPD503) only. \n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0208
Date of REC Opinion
9 Aug 2019
REC opinion
Further Information Favourable Opinion