Back to resultsIncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity (NT-Spin)
Primary Purpose
Upper Limb Spasticity
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
Sponsored by
About this trial
This is an interventional treatment trial for Upper Limb Spasticity
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT00465738
First Posted
April 24, 2007
Last Updated
December 21, 2010
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00465738
Brief Title
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
Acronym
NT-Spin
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL
Arm Type
Experimental
Arm Description
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.
Arm Title
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
Other Intervention Name(s)
incobotulinumtoxinA, Xeomin, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
Intervention Description
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.
Primary Outcome Measure Information:
Title
Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set
Description
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.
Time Frame
At week 4
Secondary Outcome Measure Information:
Title
Responder in DAS at Week 4 - Full Analysis Set
Description
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Time Frame
week 4
Title
Responder in DAS at Week 12 - Full Analysis Set
Description
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Time Frame
week 12
Title
Responder in DAS at Follow up - Full Analysis Set
Description
Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.
Time Frame
follow up visit, between week 12 and week 20
Title
Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set
Description
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.
Time Frame
Week 4
Title
Responder in FAT at Week 12 - Full Analysis Set
Description
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.
Time Frame
Week 12
Title
Responder in FAT at Follow up - Full Analysis Set
Description
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.
Time Frame
follow up visit, between week 12 and week 20
Title
Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set
Description
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.
Time Frame
week 4
Title
Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 12
Title
Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
follow up visit, between week 12 and week 20
Title
Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 4
Title
Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 12
Title
Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
follow up visit, between week 12 and week 20
Title
Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 4
Title
Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 12
Title
Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
follow up visit, between week 12 and week 20
Title
Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 4
Title
Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 12
Title
Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
follow up visit, between week 12 and week 20
Title
Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 4
Title
Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
week 12
Title
Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set
Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.
Time Frame
follow up visit, between week 12 and week 20
Title
Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension
Description
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.
Time Frame
baseline, week 4, week 12, follow up (between week 12 and week 20)
Title
Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension
Description
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.
Time Frame
baseline, week 4, week 12, follow up (between week 12 and week 20)
Title
Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion
Description
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.
Time Frame
baseline, week 4, week 12, follow up (between week 12 and week 20)
Title
Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion
Description
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.
Time Frame
baseline, week 4, week 12, follow up (between week 12 and week 20)
Title
Investigator's Global Assessment of Treatment Response (GATR) - Full Analysis Set
Description
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.
Time Frame
week 4
Title
Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set
Description
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.
Time Frame
week 4
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding
Description
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.
Time Frame
week 4
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding
Description
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.
Time Frame
week 12
Title
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding
Description
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.
Time Frame
follow up visit, between week 12 and week 20
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming
Description
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.
Time Frame
week 4
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming
Description
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.
Time Frame
week 12
Title
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming
Description
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.
Time Frame
follow up visit, between week 12 and week 20
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use
Description
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.
Time Frame
week 4
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use
Description
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.
Time Frame
week 12
Title
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use
Description
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.
Time Frame
follow up visit, between week 12 and week 20
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering
Description
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.
Time Frame
week 4
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering
Description
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.
Time Frame
week 12
Title
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering
Description
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.
Time Frame
follow up visit, between week 12 and week 20
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing
Description
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.
Time Frame
week 4
Title
Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing
Description
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.
Time Frame
week 12
Title
Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing
Description
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.
Time Frame
follow up visit, between week 12 and week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Barnes, MD, FRCP
Organizational Affiliation
Hunters Moor Hospital, Newcastle-upon-Tyne, UK
Official's Role
Principal Investigator
Facility Information:
City
Hermagor
Country
Austria
City
Innsbruck
Country
Austria
City
Vienna
Country
Austria
City
Besancon
Country
France
City
Garches
Country
France
City
Lille
Country
France
City
Paris
Country
France
City
Beelitz-Heilstaetten
Country
Germany
City
Duesseldorf
Country
Germany
City
Gladbeck
Country
Germany
City
Bari
Country
Italy
City
Costa Masnaga
Country
Italy
City
Messina
Country
Italy
City
Mestre
Country
Italy
City
Milano
Country
Italy
City
Rome
Country
Italy
City
Lisbon
Country
Portugal
City
Tocha
Country
Portugal
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Terrassa
Country
Spain
City
Bern
Country
Switzerland
City
Nottwil
Country
Switzerland
City
Kent
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
Plymouth
Country
United Kingdom
City
Wakefield
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
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