BOTOX® Treatment in Adult Patients with Upper Limb Spasticity
Research type
Research Study
Full title
BOTOX® Treatment in Adult Patients with Upper Limb Spasticity
IRAS ID
138450
Contact name
Austen Peter Moore
Contact email
Sponsor organisation
Allergan Ltd
Eudract number
2013-002346-37
Clinicaltrials.gov Identifier
N/A
Research summary
The aim of this study is to evaluate the safety and efficacy of BOTOX in the treatment of adults who have experienced a stroke resulting in spasticity in one of their upper limbs.
This is a phase 3 study that consists of a randomised(treatment will be allocated by chance), double-blind(neither the researcher or patient will know which dose is administered), placebo (dummy drug)-controlled, parallel-group single treatment cycle. Individual patient participation will be up to 20 weeks. This includes a screening period of up to 4 weeks and a double-blind placebo-controlled treatment cycle of 12 to 16 weeks.
Male or female participants between the ages of 18 and 80 with spasticity in one of their upper limbs due to stroke will be enrolled in the study.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0157
Date of REC Opinion
21 May 2014
REC opinion
Further Information Favourable Opinion