Allergan Protocol 191622-116 - Version Final dated 28-Oct-2011

• Research type

  Research Study

• Full title

  BOTOX® Treatment in Adult Patients with Post-Stroke Lower Limb Spasticity

• IRAS ID

  101250

• Contact name

  Austen Moore

• Sponsor organisation

  Allergan Ltd

• Eudract number

  2011-004980-63

• ISRCTN Number

  na

• Research summary

  Phase 3 study to evaluate the safety and efficacy of BOTOX© in the treatment of adult post-stroke lower limb spasticity involving the ankle. Male and female subjects aged between 18 and 85 will be enrolled in the study. This multicenter study consists of a double-blind, placebo-controlled phase followed by an open-label phase. The total duration of study participation for each participant should not exceed 58 weeks which includes up to 15 scheduled clinic visits and up to 3 telephone visits. The study is being funded by Allergan Ltd and is planned to be conducted in Canada, Czech Republic, Denmark, Finland, Germany, Hungary, Norway, Poland, Sweden, Turkey, UK, USA.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  12/SC/0226

• Date of REC Opinion

  8 Jun 2012

• REC opinion

  Further Information Favourable Opinion