Clinical Trial Results:
Prospective, Open-label, Non-randomized, Single-arm, Multi-center Dose Titration Study to Investigate the Safety and Efficacy of NT 201 in Subjects Deemed to Require Total Body Doses of 800 U of NT 201 During the Course of the Study for the Treatment of Upper and Lower Limb Spasticity of the Same Body Side due to Cerebral Causes
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Summary
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EudraCT number |
2010-020886-26 |
Trial protocol |
DE ES PT IT |
Global end of trial date |
12 Sep 2014
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Results information
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Results version number |
v2(current) |
This version publication date |
14 Sep 2017
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First version publication date |
16 Jul 2016
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MRZ60201_3053_1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01603459 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Merz Pharmaceuticals GmbH
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Sponsor organisation address |
Eckenheimer Landstrasse 100, Frankfurt/M, Germany, 60318
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Public contact |
Public Disclosure Manager, Merz Pharmaceuticals GmbH, clinicaltrials@merz.de
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Scientific contact |
Public Disclosure Manager, Merz Pharmaceuticals GmbH, clinicaltrials@merz.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Sep 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Sep 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Sep 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating subjects with spasticity on one body side due to cerebral causes.
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Protection of trial subjects |
High medical and ethical standards were followed in accordance with Good Clinical Practice and other applicable regulations. In addition, an independent data monitoring committee was in charge of monitoring subject safety while the study was ongoing.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 May 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 19
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Country: Number of subjects enrolled |
Canada: 3
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Country: Number of subjects enrolled |
Germany: 45
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Country: Number of subjects enrolled |
Italy: 33
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Country: Number of subjects enrolled |
Norway: 7
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Country: Number of subjects enrolled |
Portugal: 18
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Country: Number of subjects enrolled |
Spain: 12
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Country: Number of subjects enrolled |
United States: 18
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Worldwide total number of subjects |
155
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EEA total number of subjects |
134
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
115
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From 65 to 84 years |
40
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85 years and over |
0
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Recruitment
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Recruitment details |
The clinical study was conducted at 30 sites located in Canada, France, Germany, Italy, Norway, Portugal, Spain, and the United States of America. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 193 subjects were screened for the study, of which 155 were enrolled into the study. All enrolled subjects were treated with study drug according to the study protocol. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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IncobotulinumtoxinA (Xeomin) (up to 800 Units) | ||||||||||||||||||||
Arm 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. IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units. For each injection session: Solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 milliliter (mL) per 100 units; Mode of administration: Intramuscular injection. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
NT 201
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Investigational medicinal product code |
NT 201
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Other name |
Xeomin
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects to receive Intramuscular injection of solution prepared by reconstitution of powder with 0.9% NaCl, 400-800 units, volume 2.0 mL per 100 units.
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Baseline characteristics reporting groups
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Reporting group title |
IncobotulinumtoxinA (Xeomin) (up to 800 Units)
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Reporting group description |
IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units. For each injection session: Solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 milliliter (mL) per 100 units; Mode of administration: Intramuscular injection. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IncobotulinumtoxinA (Xeomin) (up to 800 Units)
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Reporting group description |
IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units. For each injection session: Solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 milliliter (mL) per 100 units; Mode of administration: Intramuscular injection. | ||
Subject analysis set title |
IncobotulinumtoxinA (Xeomin): Injection Cycle 1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
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Subject analysis set title |
IncobotulinumtoxinA (Xeomin): Injection Cycle 2
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
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Subject analysis set title |
IncobotulinumtoxinA (Xeomin): Injection Cycle 3
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
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Subject analysis set title |
IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
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Subject analysis set title |
IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
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Subject analysis set title |
IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
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Subject analysis set title |
IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
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Subject analysis set title |
IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
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Subject analysis set title |
IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
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End point title |
Occurrence of Treatment-emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication [1] | ||||||||||||||||||||||||||||||||||||
End point description |
Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected. Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.
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End point type |
Primary
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End point timeframe |
From Baseline to Week 36-48
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Investigator’s Global Assessment of Tolerability in Subjects [2] | ||||||||||||||||||||||||||||||||
End point description |
A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. SES only subjects treated in the respective injection cycle were analyzed.
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End point type |
Primary
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End point timeframe |
Up to Week 48
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be analyzed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | ||||||||||||||||||||||||||||
End point description |
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). The full analysis set (FAS) is the subset of all subjects who were exposed to study medication at least once. Only subjects treated in the target joint in the respective cycle were analyzed.
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End point type |
Secondary
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End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits | ||||||||||||||||
End point description |
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). FAS, observed cases, only subjects treated in the target joint in the respective cycle were analyzed.
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End point type |
Secondary
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End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles | ||||||||||||||||
End point description |
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). FAS, observed cases, only subjects treated in
the target joint in the respective cycle were analyzed.
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End point type |
Secondary
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End point timeframe |
From Study Baseline to Week 4, 16-20 and 28-36
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit from Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | ||||||||||||||||
End point description |
The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). FAS, observed cases, only subjects treated in the target joint in the respective cycle were analyzed.
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End point type |
Secondary
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End point timeframe |
Injection cycle 1: Study baseline to week 12-16 (= cycle 2 baseline), Injection cycle 2: Study baseline to week 24-32 (= cycle 3 baseline), Injection cycle 3: Study baseline to week 36-48 (= end of cycle 3)
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Internally rotated/extended/adducted shoulder (n= 52, 52, 69, 68, 84, 83). Here, "n" is number of subjects analyzed for this endpoint at given time point. FAS- only subjects treated in the respective pattern in the respective injection cycle. Here '99999' indicates no data was available.
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End point type |
Secondary
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End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Internally rotated/extended/adducted shoulder (n= 52, 68, 83). Here, "n" is number of subjects analyzed for this endpoint at given time point. FAS- only subjects treated in the respective pattern in the respective injection cycle were analyzed. Here '99999' indicates no data was available.
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End point type |
Secondary
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End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Internally rotated/extended/adducted shoulder (n= 52, 68, 83). Here, "n" is number of subjects analyzed for this endpoint at given time point. FAS- only subjects treated in the respective pattern of respective injection cycle were analyzed. Here '99999' indicates no data was available.
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End point type |
Secondary
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End point timeframe |
From Study Baseline to Week 4, 16-20 and 28-36
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Internally rotated/extended/adducted shoulder (n= 69, 84, 82). Here, "n" is number of subjects analyzed for this endpoint at given time point. FAS- only subjects treated in the respective pattern of respective injection cycle were analyzed.
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End point type |
Secondary
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End point timeframe |
Injection cycle 1: Study baseline to week 12-16 (= cycle 2 baseline), Injection cycle 2: Study baseline to week 24-32 (= cycle 3 baseline), Injection cycle 3: Study baseline to week 36-48 (= end of cycle 3)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | ||||||||||||||||||||||||||||
End point description |
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, that is, the maximum value for the treated body side was 52. FAS - only subjects treated in the respective injection cycle were analyzed.
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End point type |
Secondary
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End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits | ||||||||||||||||
End point description |
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52. FAS - only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles | ||||||||||||||||
End point description |
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52. The FAS is the subset of all subjects who were exposed to study medication at least once.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Injection cycle 1: Study baseline to week 12-16 (= cycle 2 baseline), Injection cycle 2: Study baseline to week 24-32 (= cycle 3 baseline), Injection cycle 3: Study baseline to week 36-48 (= end of cycle 3)
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | ||||||||||||||||
End point description |
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52. The FAS is the subset of all subjects who were exposed to study medication at least once.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Injection cycle 1”: Study baseline to week 12-16 (= cycle 2 baseline), “Injection cycle 2“: Study baseline to week 24-32 (= cycle 3 baseline), “Injection cycle 3“: Study baseline to week 36-48 (= end of cycle 3)
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Functional Ambulation Classification (FAC) Scale Scores | ||||||||||||||||||||||||||||
End point description |
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits | ||||||||||||||||
End point description |
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. FAS - only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Functional ambulation classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles | ||||||||||||||||
End point description |
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Study Baseline to Week 4, 16-20 and 28-36
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | ||||||||||||||||
End point description |
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent. FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Injection cycle 1: Study baseline to week 12-16 (= cycle 2 baseline), Injection cycle 2: Study baseline to week 24-32 (= cycle 3 baseline), Injection cycle 3: Study baseline to week 36-48 (= end of cycle 3)
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Global Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively | ||||||||||||||||||||||||
End point description |
Change in goal attainment T-scores from respective injection cycle(IC) baseline visit. GAS measures extent to which subject's individual goals are achieved in course of intervention. Subject and treating team, identify 2 personal goals for each treated limb at each IC. Investigator rates GAS score for each IC. Degree of goal attainment is rated on 5-point scale (-2,-1,0,+1,+2;study baseline set to -1). In order to account for interindividual differences the number of goals, ratings are computed with Kiresuk formula (Kiresuk & Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring degree of goal attainment at each visit. A score of 50 indicates that,individual has reached the expected level of achievement for all goals. Size of change from measurement to measurement indicates incremental change towards/away from goal attainment. Positive values indicate a higher goal attainment. Here,"n" number of subjects analyzed for endpoint at given time point.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| Notes [3] - FAS - only subjects treated in the respective injection cycle were analyzed. [4] - FAS - only subjects treated in the respective injection cycle were analyzed. [5] - FAS - only subjects treated in the respective injection cycle were analyzed. |
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | ||||||||||||||||||||||||||||
End point description |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value. FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits | ||||||||||||||||
End point description |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each subject's target domain value change. FAS - only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 4 of Each Cycle
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles | ||||||||||||||||
End point description |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each subject's target domain value. FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Study Baseline to Week 4, 16-20 and 28-36
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | ||||||||||||||||
End point description |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each subject's target domain value change. FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Injection cycle 1: Study baseline to week 12-16 (= cycle 2 baseline), Injection cycle 2: Study baseline to week 24-32 (= cycle 3 baseline), Injection cycle 3: Study baseline to week 36-48 (= end of cycle 3)
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Global Assessment of Efficacy Scores | ||||||||||||||||||||||||||||||||||||
End point description |
Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. FAS - only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Week 12-16, 24-32 and 36-48
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perceptionand mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems.
Usual activities: Frequency 1, 2 and 3 (n= 155, 155, 152, 148, 140, 138); Pain/discomfort: Frequency 1, 2 and 3 (n= 155, 155, 152, 149, 140, 138); Anxiety/depression: Frequency 1, 2 and 3 (n= 155, 155, 152, 149, 140, 138). Here, "n" is number of subjects analyzed for this endpoint at given time point. FAS- only subjects treated in the respective injection cycle were analyzed.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | ||||||||||||||||||||||||||||
End point description |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome). FAS - only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change of EuroQoL 5-dimensions questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories. Here, "n" is number of subjects analyzed for this endpoint at given time point. FAS - only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Change in Visual Analogue Scale of EuroQoL 5-dimensions questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | ||||||||||||||||
End point description |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome). FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Cycle Baseline to Week 4 of Each Cycle
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change of EuroQoL 5-dimensions questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories. Here, "n" is number of subjects analyzed for this endpoint at given time point. FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Study Baseline to Week 4, 16-20 and 28-36
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Change in Visual Analogue Scale of EuroQoL 5-dimensions questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | ||||||||||||||||
End point description |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate,better outcome). This table: Positive values indicate improvement. FAS- only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Study Baseline to Week 4, 16-20 and 28-36
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change of EuroQoL 5-dimensions questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories. FAS - only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Injection cycle 1: Study baseline to week 12-16 (= cycle 2 baseline), Injection cycle 2: Study baseline to week 24-32 (= cycle 3 baseline), Injection cycle 3: Study baseline to week 36-48 (= end of cycle 3)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Change in Visual Analogue Scale of EuroQoL 5-dimensions questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | ||||||||||||||||
End point description |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement. FAS - only subjects treated in the respective injection cycle were analyzed.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Injection cycle 1: Study baseline to week 12-16 (= cycle 2 baseline), Injection cycle 2: Study baseline to week 24-32 (= cycle 3 baseline), Injection cycle 3: Study baseline to week 36-48 (= end of cycle 3)
|
||||||||||||||||
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From the time point of first injection until 16 weeks after last injection
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
IncobotulinumtoxinA (Xeomin) (up to 800 Units)
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Reporting group description |
IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units. For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Nov 2011 |
Changes related to informed consent, subject card, objectives, study design, inclusion/exclusion criteria, discontinuation of subjects, Investigational product (IP) administration, efficacy variables, and safety variables. |
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23 Feb 2012 |
Introduction of forced expiratory volume in 1 second (FEV1) and maximal inspiratory pressure (MIP) as additional safety parameters. Introduction of study-wide stopping rules. Additional safety visits 8 weeks after injection, additional telephone contacts 2 weeks after injection. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
