Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke (PURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01392300
First received: July 7, 2011
Last updated: January 13, 2016
Last verified: January 2016
Results First Received: January 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Post-stroke Spasticity of the Upper Limb.
Interventions: Drug: IncobotulinumtoxinA (400 Units)
Drug: Placebo Comparator

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
Double-blind Placebo Comparator Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections) IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment

Participant Flow for 2 periods

Period 1:   Main Period (MP)
    Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)     Double-blind Placebo Comparator     OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)  
STARTED     210     107     0  
COMPLETED     199     100     0  
NOT COMPLETED     11     7     0  
Predefined discontinuation criteria                 2                 3                 0  
Withdrawal by Subject                 5                 1                 0  
Lost to Follow-up                 3                 3                 0  
Non-compliance                 1                 0                 0  

Period 2:   Open Label Extension (OLEX) Period
    Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)     Double-blind Placebo Comparator     OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)  
STARTED     0 [1]   0 [1]   299 [1]
COMPLETED     0     0     248  
NOT COMPLETED     0     0     51  
Protocol Violation                 0                 0                 13  
Lack of Efficacy                 0                 0                 3  
Non-compliance                 0                 0                 1  
Death                 0                 0                 4  
Adverse Event                 0                 0                 7  
Withdrawal by Subject                 0                 0                 17  
Lost to Follow-up                 0                 0                 6  
[1] Subjects from double-blind arms were switched to arm OLEX IncobotulinumtoxinA (Xeomin) (...)



  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.
Safety evaluation set (The subset of all subjects who were exposed to investigational product in the main period)

Reporting Groups
  Description
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
Double-blind Placebo Comparator Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
Total Total of all reporting groups

Baseline Measures
    Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)     Double-blind Placebo Comparator     Total  
Number of Participants  
[units: participants]
  210     107     317  
Age  
[units: years]
Mean (Standard Deviation)
  55.3  (11.9)     57.8  (10.9)     56.1  (11.6)  
Gender  
[units: participants]
     
Female     120     61     181  
Male     90     46     136  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     4     0     4  
Not Hispanic or Latino     22     12     34  
Unknown or Not Reported     184     95     279  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     27     13     40  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     6     3     9  
White     175     91     266  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     26     12     38  
Czech Republic     46     25     71  
Hungary     23     9     32  
Poland     66     38     104  
Russian Federation     22     10     32  
Germany     1     0     1  
India     26     13     39  



  Outcome Measures
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1.  Primary:   Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern   [ Time Frame: Week 4 ]

2.  Primary:   Investigator's Global Impression of Change   [ Time Frame: Week 4 ]

3.  Secondary:   Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern   [ Time Frame: Week 4 ]

4.  Secondary:   Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern   [ Time Frame: Week 8 ]

5.  Secondary:   Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern   [ Time Frame: Week 12 ]

6.  Secondary:   Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist   [ Time Frame: Week 4 ]

7.  Secondary:   Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist   [ Time Frame: Week 8 ]

8.  Secondary:   Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist   [ Time Frame: Week 12 ]

9.  Secondary:   Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow   [ Time Frame: Week 4 ]

10.  Secondary:   Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow   [ Time Frame: Week 8 ]

11.  Secondary:   Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow   [ Time Frame: Week 12 ]

12.  Secondary:   Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist   [ Time Frame: Week 4 ]

13.  Secondary:   Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist   [ Time Frame: Week 8 ]

14.  Secondary:   Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist   [ Time Frame: Week 12 ]

15.  Secondary:   Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm   [ Time Frame: Week 4 ]

16.  Secondary:   Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm   [ Time Frame: Week 8 ]

17.  Secondary:   Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm   [ Time Frame: Week 12 ]

18.  Secondary:   Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm   [ Time Frame: Week 4 ]

19.  Secondary:   Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm   [ Time Frame: Week 8 ]

20.  Secondary:   Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm   [ Time Frame: Week 12 ]

21.  Secondary:   Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.   [ Time Frame: Week 4 ]

22.  Secondary:   Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.   [ Time Frame: Week 8 ]

23.  Secondary:   Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.   [ Time Frame: Week 12 ]

24.  Secondary:   Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.   [ Time Frame: Week 4 ]

25.  Secondary:   Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.   [ Time Frame: Week 8 ]

26.  Secondary:   Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.   [ Time Frame: Week 12 ]

27.  Secondary:   Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.   [ Time Frame: Week 4 ]

28.  Secondary:   Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.   [ Time Frame: Week 8 ]

29.  Secondary:   Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.   [ Time Frame: Week 12 ]

30.  Secondary:   Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.   [ Time Frame: Week 4 ]

31.  Secondary:   Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.   [ Time Frame: Week 8 ]

32.  Secondary:   Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.   [ Time Frame: Week 12 ]

33.  Secondary:   Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.   [ Time Frame: Week 4 ]

34.  Secondary:   Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.   [ Time Frame: Week 8 ]

35.  Secondary:   Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.   [ Time Frame: Week 12 ]

36.  Secondary:   Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain   [ Time Frame: Week 4 ]

37.  Secondary:   Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain   [ Time Frame: Week 8 ]

38.  Secondary:   Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain   [ Time Frame: Week 12 ]

39.  Secondary:   Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene   [ Time Frame: Week 4 ]

40.  Secondary:   Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene   [ Time Frame: Week 8 ]

41.  Secondary:   Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene   [ Time Frame: Week 12 ]

42.  Secondary:   Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing   [ Time Frame: Week 4 ]

43.  Secondary:   Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing   [ Time Frame: Week 8 ]

44.  Secondary:   Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing   [ Time Frame: Week 12 ]

45.  Secondary:   Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position   [ Time Frame: Week 4 ]

46.  Secondary:   Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position   [ Time Frame: Week 8 ]

47.  Secondary:   Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position   [ Time Frame: Week 12 ]

48.  Secondary:   Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain   [ Time Frame: Week 4 ]

49.  Secondary:   Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain   [ Time Frame: Week 8 ]

50.  Secondary:   Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain   [ Time Frame: Week 12 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals GmbH
phone: +49 69 1503 1
e-mail: clinicaltrials@merz.de


Publications of Results:

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01392300     History of Changes
Other Study ID Numbers: MRZ 60201/SP/3001
2010-023043-15 ( EudraCT Number )
Study First Received: July 7, 2011
Results First Received: January 13, 2016
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration