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

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo
    ARM 1: Kind: Experimental
    Label: Placebo
  • NT 201 (Xeomin(R))Drug
    Intervention Desc: NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin.
  • IncobotulinumtoxinA (Xeomin) Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: IncobotulinumtoxinA (Xeomin)
    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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients were randomized to one of two arms: 1) NT 201 or 2) placebo. Patients were observed using Ashworth Scale score 4 weeks after treatment in wrist flexors.

Outcomes

Type Measure Time Frame Safety Issue
Primary Ashworth Score in wrist flexors.
Secondary Ashworth Score in various upper limb muscle groups.
Primary Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors Baseline, Week 4 No
Secondary Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors Baseline, Week 4 No
Secondary Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Time to Onset of Treatment Effect Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect No
Secondary Time to Waning of Treatment Effect Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect No
Secondary Duration of Treatment Effect Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator No
Secondary Investigator's Global Assessment of Efficacy Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Patient's Global Assessment of Efficacy Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Carer's Global Assessment of Efficacy Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene" Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene" Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene" Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing" Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing" Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing" Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position" Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position" Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position" Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain" Baseline, Week 2 No
Secondary Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain" Baseline, Week 4 No
Secondary Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain" Baseline, Week 8 No
Secondary Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Baseline, Week 4 No
Secondary Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Baseline, Week 4 No
Secondary Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Baseline, Week 4 No
Secondary Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Baseline, Week 4 No
Secondary Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No
Secondary Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Baseline, Week 4 No
Secondary Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Baseline, Week 12 No
Secondary Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm" Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest) No

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