Evaluate scales for RRB, digital biomarkers in participants with ASD

• Research type

  Research Study

• Full title

  Study to evaluate and explore scales for Repetitive and Restricted Behaviors and Digital Biomarkers in children, adolescents and adults with Autism Spectrum Disorder (ASD)

• IRAS ID

  245938

• Contact name

  Declan Murphy

• Contact email

  declan.murphy@kcl.ac.uk

• Sponsor organisation

  Roche Pharma Research & Early Development

• Duration of Study in the UK

  0 years, 11 months, 3 days

• Research summary

  Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterised by
  persistent deficits in social communication and social interaction and presence of
  repetitive patterns of behaviours, interests, or activities. The frequency of ASD is
  between 1 in 45 to 1 in 68 children. There's no 'cure' for ASD but there are a range of specialist interventions that aim to improve communication skills and help with educational and social development. BP40331 is a non-drug study which seeks to characterise different scales to measure repetitive and restricted behaviours in different ASD sub-populations over time and to explore the use of digital biomarkers. The results from this study will inform the planning and setup of subsequent drug interventional studies in programs aimed to treating restrictive and repetitive behaviours in ASD.

  The study is funded by Roche. Approximately 105 participants (90 participants with ASD and 15 healthy volunteers) will be recruited globally with around 20 participants recruited in the UK. The total duration of the study (from screening through to study completion) for each participant will be approximately 15 weeks divided as follows:

  •Screening and run-in period: up to 4 weeks.
  •Study period: 12 weeks.

  The study has been designed to identify and compare the psychological properties of different scales for Restricted and repetitive behaviours (RRBs) in participants with ASD.

  Each participant with ASD will be evaluated using several scales and tests at each visit at the clinic. A total of 4 clinic visits and 2 phone contacts are planned (screening period included). In addition, digital biomarker data will be collected from all participants. Healthy participants (i.e., children of 5-12 years of age) will be enrolled for validation of biomarkers only.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  18/LO/1019

• Date of REC Opinion

  20 Jun 2018

• REC opinion

  Unfavourable Opinion