Drug Utilization Study on the Risk Minimisation Tools for Sialanar

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Name of medicine:
  SIALANAR
• Medical condition to be studied:
  Drooling

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective is to monitor and assess effectiveness of the educational materials helping carers to adjust dose titration in response to identified anticholinergic side effects
• Outcomes:
  Incidence of anticholinergic side effects resulting in treatment dose change or cessation of Sialanar, The number of anticholinergic adverse events brought to the attention of the prescribing physician (initiator – e.g. consultant neurologist) by the carer that occurs in between the routine consultation time interval. The number of occasions and reasons Sialanar treatment is stopped due to anticholinergic adverse events. Quantify the frequency of off-label use of Sialanar
• Data analysis plan:
  Descriptive statistics will be used. The analysis will be performed per country if possible and for all countries combined (if possible for same data categories). Demographic characteristics and Sialanar treatment outcomes will be summarised according to diagnosis (if possible and sufficient numbers).