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

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Post-stroke Upper Limb Spasticity

Treatments: Drug: Placebo; Drug: IncobotulinumtoxinA (Xeomin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432666

MRZ 60201-0410

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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148 participants in 2 patient groups, including a placebo group

IncobotulinumtoxinA (Xeomin)

Experimental group

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

Treatment:

Drug: IncobotulinumtoxinA (Xeomin)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo