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

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00465738
First received: April 24, 2007
Last updated: December 21, 2010
Last verified: December 2010
Results First Received: August 31, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Upper Limb Spasticity
Intervention: Drug: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
216 female and male subjects with upper limb spasticity caused by either stroke, brain injury, spinal cord injury, multiple sclerosis or cerebral palsy were screened starting February 2007. Recruitment advertisements according to local law and approved by the responsible IEC were published as needed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The protocol contained a screening period of 7 days to allow evaluation of laboratory and ECGs in order to determine eligibility. 24 subjects were screening failures due to violation of selection or protocol criteria.

Reporting Groups
  Description
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL No text entered.
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL No text entered.

Participant Flow:   Overall Study
    incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL     incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL  
STARTED     97     95  
COMPLETED     91     89  
NOT COMPLETED     6     6  
Lost to Follow-up                 2                 0  
Adverse Event                 0                 1  
Withdrawal by Subject                 2                 0  
Unknown                 2                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL No text entered.
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL No text entered.
Total Total of all reporting groups

Baseline Measures
    incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL     incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL     Total  
Number of Participants  
[units: participants]
  97     95     192  
Age  
[units: years]
Mean ± Standard Deviation
  55.3  ± 14.88     55.5  ± 13.74     55.4  ± 14.29  
Gender  
[units: participants]
     
Female     48     33     81  
Male     49     62     111  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     76     78     154  
Asian     0     0     0  
Oriental     1     0     1  
Negroid     1     0     1  
Other     1     1     2  
Missing     18     16     34  



  Outcome Measures
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1.  Primary:   Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set   [ Time Frame: At week 4 ]

2.  Secondary:   Responder in DAS at Week 4 - Full Analysis Set   [ Time Frame: week 4 ]

3.  Secondary:   Responder in DAS at Week 12 - Full Analysis Set   [ Time Frame: week 12 ]

4.  Secondary:   Responder in DAS at Follow up - Full Analysis Set   [ Time Frame: follow up visit, between week 12 and week 20 ]

5.  Secondary:   Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set   [ Time Frame: Week 4 ]

6.  Secondary:   Responder in FAT at Week 12 - Full Analysis Set   [ Time Frame: Week 12 ]

7.  Secondary:   Responder in FAT at Follow up - Full Analysis Set   [ Time Frame: follow up visit, between week 12 and week 20 ]

8.  Secondary:   Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set   [ Time Frame: week 4 ]

9.  Secondary:   Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set   [ Time Frame: week 12 ]

10.  Secondary:   Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set   [ Time Frame: follow up visit, between week 12 and week 20 ]

11.  Secondary:   Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set   [ Time Frame: week 4 ]

12.  Secondary:   Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set   [ Time Frame: week 12 ]

13.  Secondary:   Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set   [ Time Frame: follow up visit, between week 12 and week 20 ]

14.  Secondary:   Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set   [ Time Frame: week 4 ]

15.  Secondary:   Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set   [ Time Frame: week 12 ]

16.  Secondary:   Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set   [ Time Frame: follow up visit, between week 12 and week 20 ]

17.  Secondary:   Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set   [ Time Frame: week 4 ]

18.  Secondary:   Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set   [ Time Frame: week 12 ]

19.  Secondary:   Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set   [ Time Frame: follow up visit, between week 12 and week 20 ]

20.  Secondary:   Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set   [ Time Frame: week 4 ]

21.  Secondary:   Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set   [ Time Frame: week 12 ]

22.  Secondary:   Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set   [ Time Frame: follow up visit, between week 12 and week 20 ]

23.  Secondary:   Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension   [ Time Frame: baseline, week 4, week 12, follow up (between week 12 and week 20) ]

24.  Secondary:   Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension   [ Time Frame: baseline, week 4, week 12, follow up (between week 12 and week 20) ]

25.  Secondary:   Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion   [ Time Frame: baseline, week 4, week 12, follow up (between week 12 and week 20) ]

26.  Secondary:   Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion   [ Time Frame: baseline, week 4, week 12, follow up (between week 12 and week 20) ]

27.  Secondary:   Investigator’s Global Assessment of Treatment Response (GATR) - Full Analysis Set   [ Time Frame: week 4 ]
  Hide Outcome Measure 27

Measure Type Secondary
Measure Title Investigator’s Global Assessment of Treatment Response (GATR) - Full Analysis Set
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.

Reporting Groups
  Description
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL No text entered.
incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL No text entered.

Measured Values
    incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL     incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL  
Number of Participants Analyzed  
[units: participants]
  97     95  
Investigator’s Global Assessment of Treatment Response (GATR) - Full Analysis Set  
[units: units on a scale]
Mean ± Standard Error
  1.66  ± 0.106     1.59  ± 0.106  

No statistical analysis provided for Investigator’s Global Assessment of Treatment Response (GATR) - Full Analysis Set



28.  Secondary:   Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set   [ Time Frame: week 4 ]

29.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding   [ Time Frame: week 4 ]

30.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding   [ Time Frame: week 12 ]

31.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding   [ Time Frame: follow up visit, between week 12 and week 20 ]

32.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming   [ Time Frame: week 4 ]

33.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming   [ Time Frame: week 12 ]

34.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming   [ Time Frame: follow up visit, between week 12 and week 20 ]

35.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use   [ Time Frame: week 4 ]

36.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use   [ Time Frame: week 12 ]

37.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use   [ Time Frame: follow up visit, between week 12 and week 20 ]

38.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering   [ Time Frame: week 4 ]

39.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering   [ Time Frame: week 12 ]

40.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering   [ Time Frame: follow up visit, between week 12 and week 20 ]

41.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing   [ Time Frame: week 4 ]

42.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing   [ Time Frame: week 12 ]

43.  Secondary:   Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing   [ Time Frame: follow up visit, between week 12 and week 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


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