Long-term Study of BOTOX® treatment in Adult Patients with Upper Limb
Research type
Research Study
Full title
Long-term Study of BOTOX® Treatment in Adult Patients with Upper Limb Spasticity
IRAS ID
152348
Contact name
Austen Peter Moore
Contact email
Sponsor organisation
Allergan Ltd
Eudract number
2013-002327-42
Clinicaltrials.gov Identifier
N/A
Research summary
The aim of this study is to evaluate the long term safety and efficacy of repeat doses 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), parallel-group single treatment cycle. Patients will participate in the study for at least 48 weeks and should have at least 12 weeks follow-up since their last treatment prior to exiting the study. The minimum duration is therefore 48 weeks, and the maximum duration is approximately 60 weeks (for patients who receive their last treatment at week 48 with 12 weeks posttreatment follow-up).
Study 191622-129 includes both patients who have directly rolled over from the preceding double-blind, placebo-controlled study, Study 191622-127, as well as de novo patients (ie, patients who did not participate in Study 191622-127).
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/0156
Date of REC Opinion
21 May 2014
REC opinion
Further Information Favourable Opinion