IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity (NT-Spin)

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00465738
First received: April 24, 2007
Last updated: December 21, 2010
Last verified: December 2010
  Purpose

This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).


Condition Intervention Phase
Upper Limb Spasticity
Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Observer-blind, Parallel-group, Multi-center Trial to Assess Efficacy and Safety of Two Different Dilutions of incobotulinumtoxinA (Xeomin) in Patients With Upper Limb Spasticity

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.


Secondary Outcome Measures:
  • Responder in DAS at Week 4 - Full Analysis Set [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.

  • Responder in DAS at Week 12 - Full Analysis Set [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.

  • Responder in DAS at Follow up - Full Analysis Set [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.

  • Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.

  • Responder in FAT at Week 12 - Full Analysis Set [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.

  • Responder in FAT at Follow up - Full Analysis Set [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.

  • Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a "catch" when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension.

  • Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.

  • Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension [ Time Frame: baseline, week 4, week 12, follow up (between week 12 and week 20) ] [ Designated as safety issue: No ]
    For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.

  • Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension [ Time Frame: baseline, week 4, week 12, follow up (between week 12 and week 20) ] [ Designated as safety issue: No ]
    For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.

  • Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion [ Time Frame: baseline, week 4, week 12, follow up (between week 12 and week 20) ] [ Designated as safety issue: No ]
    For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.

  • Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion [ Time Frame: baseline, week 4, week 12, follow up (between week 12 and week 20) ] [ Designated as safety issue: No ]
    For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.

  • Investigator's Global Assessment of Treatment Response (GATR) - Full Analysis Set [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    The investigator's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.

  • Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    The patient's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.

  • Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing [ Time Frame: follow up visit, between week 12 and week 20 ] [ Designated as safety issue: No ]
    Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.


Enrollment: 216
Study Start Date: February 2007
Study Completion Date: May 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 5.0 mL of sterile sodium chloride [NaCl] 0.9% solution without preservatives. Dilution with 5.0 mL resulted in a dose of 20 units per 1.0 mL.
Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride [NaCl] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.
Other Names:
  • incobotulinumtoxinA
  • Xeomin
  • NT 201
  • Botulinum toxin type A (150 kD), free from complexing proteins
Active Comparator: incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 mL sterile of NaCl 0.9% solution without preservatives. Dilution with 2.0 mL resulted in a dose of 50 units per 1.0 mL.
Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride [NaCl] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.
Other Names:
  • incobotulinumtoxinA
  • Xeomin
  • NT 201
  • Botulinum toxin type A (150 kD), free from complexing proteins

Detailed Description:

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins. Injected into a muscle, incobotulinumtoxinA causes a reversible local weakening of the muscle for several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. IncobotulinumtoxinA is widely used for various severe neurological conditions. There is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxinA is diluted before injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Female or male patients ≥ 18 years
  • Stable upper limb spasticity of diverse etiology
  • Focal spasticity with equal or more than 2 points on the Ashworth scale in the wrist flexors
  • Disability Assessment Scale (DAS) ≥ 2 points for primary therapeutic target at both screening and baseline visits

Main Exclusion Criteria:

  • Fixed contracture
  • Bilateral upper limb paresis/paralysis
  • Previous treatment with BoNT of any serotype and for any body region within the 4 months prior to screening
  • Previous or planned treatment with phenol- or alcohol-injection in the target limb
  • Other muscle hypertonia (e.g. rigidity)
  • Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
  • Severe atrophy of the target limb muscles
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465738

Locations
Austria
Hermagor, Austria
Innsbruck, Austria
Vienna, Austria
France
Besancon, France
Garches, France
Lille, France
Paris, France
Germany
Beelitz-Heilstaetten, Germany
Duesseldorf, Germany
Gladbeck, Germany
Italy
Bari, Italy
Costa Masnaga, Italy
Messina, Italy
Mestre, Italy
Milano, Italy
Rome, Italy
Portugal
Lisbon, Portugal
Tocha, Portugal
Spain
Barcelona, Spain
Madrid, Spain
Terrassa, Spain
Switzerland
Bern, Switzerland
Nottwil, Switzerland
United Kingdom
Kent, United Kingdom
Liverpool, United Kingdom
Plymouth, United Kingdom
Wakefield, United Kingdom
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Principal Investigator: Michael P Barnes, MD, FRCP Hunters Moor Hospital, Newcastle-upon-Tyne, UK
  More Information

No publications provided

Responsible Party: Central Medical Affairs, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00465738     History of Changes
Other Study ID Numbers: MRZ 60201 - 0607 / 1
Study First Received: April 24, 2007
Results First Received: August 31, 2010
Last Updated: December 21, 2010
Health Authority: United Kingdom: MHRA Market Towers, The Clinical Trials Unit, Dept. of Health, Rooms 12-242, Market Towers, 1 Nine Elms Lane London SW8 5NQ

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014