IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb

Completed

Phase 3 Results

Eligibility Criteria

Main

Inclusion Criteria

- Female or male patients ≥ 18 years
- ≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist)
- Focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist
- Focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist
- For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist
- For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX® or 200 Units Dysport® or 2000 Units Neurobloc® (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus
- For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX® or 240 Units Dysport® or 2400 Units Neurobloc® (type B preparation) for flexor carpi radialis
Main

Exclusion Criteria

- Spasticity of any other origin than stroke
- Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7)
- Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region
- Previous or planned treatment with phenol- or alcohol-injection in the target limb
- Previous surgical treatment of spasticity in the target muscle(s)
- Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch
- Severe atrophy of the target limb muscles