The SPACE Study: MRZ 60201_0048_5 Version Final 1.0

• Research type

  Research Study

• Full title

  A non-interventional study to evaluate treatment with Botulinum neurotoxin type A in treatment-naïve subjects with spasticity treated according to common clinical practice

• IRAS ID

  70003

• Contact name

  Julian, Paul Harriss

• Sponsor organisation

  Merz Pharma UK Ltd

• ISRCTN Number

  Not Submitted

• Research summary

  The purpose of this study is to find out about the effectiveness, safety and health related economics of the treatment of patients with spasticity that have never previously been treated with Botulinum neurotoxin type A medications.This is a non-interventional study, also known as observational study. These types of studies are normally carried out after a medicine has been given a license and the drug is available in pharmacies for sale and for the doctor??s to use to treat patients. This study will help to provide further information about Botulinum neurotoxin medications. We hope that the observations and notes that will be taken during your treatment will give us knowledge that may help improve spasticity treatment for future patients. We are not testing any new medicine on patients. Study doctors will not diagnose or perform any other additional measures on patients as part of this study. The doctor will prescribe the medication for the patient in the usual manner. All other aspects of the patient??s treatment regimen, e.g. dose, injection location or intervals will be at the doctor??s clinical discretion in a way that best fit the patients individual treatment needs. The doctor will inject the patient with Botulinum neurotoxin type A products that are marketed and available in the United Kingdom. An example of Botulinum neurotoxin Type A medicine includes brand names such as Xeomin©, Botox©, and Dysport©. One of the mentioned medicines will be given to the patient by the doctor under conditions of his clinical practice in daily routine, based on the applicable UK labelling. This non-interventional study will be carried out in various countries in up to 100 sites with up to 1,000 participating patients. Patients will be observed in this study for two years.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/H0720/6

• Date of REC Opinion

  10 Mar 2011

• REC opinion

  Further Information Favourable Opinion