IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb
Condition: Post-stroke Upper Limb Spasticity
MeSH terms: Muscle Spasticity; Stroke
Intervention: IncobotulinumtoxinA (Xeomin); Placebo
Intervention description: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection; Placebo
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing
      proteins, i.e. free from proteins other than the active toxin. Injected into the muscle,
      incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used
      for treatment of various neurological conditions. This study will investigate the efficacy
      and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the
      upper limb.
    

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