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Trial record 1 of 1 for:    y-52-52120-148
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Dysport® Adult Upper Limb Spasticity Extension Study

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ClinicalTrials.gov Identifier: NCT01313312
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Nervous System Disorders
Intervention: Drug: Dysport®

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was designed as a multicentre study and included a total of 34 investigational sites in Belgium, the Czech Republic, France, Hungary, Italy, Poland, Russia, Slovakia and the United States of America (US) that included at least one subject. This study was an open label extension to the double blind Study 145 (Y-52-52120-145).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 227 subjects who completed Study 145, 4 subjects entered an observational phase and never received treatment with Dysport® in this open label extension study (Study 148). The remaining 223 subjects were eligible for retreatment and progressed to Study 148. In addition, 31 of the 34 de novo subjects screened were included in this study.

Reporting Groups
  Description
Total Dysport®

A total of 254 subjects in the open label study received between 1 and 5 intramuscular (i.m.) injections of Dysport® according to their individual needs, for a period of up to 12 months.

All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.

From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U.

Participant Flow:   Overall Study
    Total Dysport®
STARTED   258 
Cycle 1   254 
Cycle 2   229 
Cycle 3   175 
Cycle 4   81 
Cycle 5   11 
COMPLETED   222 
NOT COMPLETED   36 
Adverse Event                5 
Withdrawal by Subject                18 
Lack of Efficacy                3 
Investigator Decision                1 
Observational Phase                1 
Subject Withdrawn Early in Error                4 
Did Not Receive Treatment with Dysport®                4 



  Baseline Characteristics

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.
Baseline characteristics are reported for the 254 Subjects who entered this open label study (223 from Study 145 and 31 de novo subjects) and received at least one open label injection of Dysport®.

Reporting Groups
  Description
Total Dysport®

A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.

All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.

From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U.

Baseline Measures
   Total Dysport® 
Overall Participants Analyzed 
[Units: Participants]
 		 254 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      0   0.0% 
Between 18 and 65 years      201  79.1% 
>=65 years      53  20.9% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 52.4  (14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      91  35.8% 
Male      163  64.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		 
Hispanic or Latino      16   6.3% 
Not Hispanic or Latino      238  93.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		 
American Indian or Alaska Native      0   0.0% 
Asian      7   2.8% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      27  10.6% 
White      218  85.8% 
More than one race      2   0.8% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 1

2.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Diastolic and Systolic Blood Pressure (BP)   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 2

3.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Heart Rate (HR)   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 3

4.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Red Blood Cell (RBC) Count   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 4

5.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 5

6.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Haematocrit   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 6

7.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Haemoglobin (MCH)   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 7

8.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Volume (MCV)   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 8

9.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 9

10.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in 12-Lead Electrocardiogram (ECG)   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 10

11.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 11

12.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Total Bilirubin and Creatinine   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 12

13.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 13

14.  Primary:   Mean Change From Baseline to End of Study/Early Withdrawal in 12 Lead ECG - HR   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 14

15.  Primary:   Number of Subjects With Botulinum Toxin A Binding and Neutralising Putative Antibodies   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 15

16.  Secondary:   Mean Change From Baseline Modified Ashworth Scale (MAS) in the Overall Primary Targeted Muscle Group (PTMG) for Upper Limb at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 16

17.  Secondary:   Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Overall PTMG   [ Time Frame: At Week 4 ]
  Show Outcome Measure 17

18.  Secondary:   Mean Change From Baseline MAS in the Extrinsic Finger Flexors at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 18

19.  Secondary:   Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Extrinsic Finger Flexors at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 19

20.  Secondary:   Mean Change From Baseline MAS in the Wrist Flexors at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 20

21.  Secondary:   Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Wrist Flexors at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 21

22.  Secondary:   Mean Change From Baseline MAS in the Elbow Flexors at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 22

23.  Secondary:   Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Elbow Flexors at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 23

24.  Secondary:   Mean Change From Baseline MAS in the Shoulder Extensors at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 24

25.  Secondary:   Physician's Global Assessment (PGA) of Treatment Response at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 25

26.  Secondary:   Mean Change From Baseline in Disability Assessment Scale (DAS) Score for the Principal Target of Treatment (PTT) at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 26

27.  Secondary:   Percentage of Subjects With at Least 1 Grade Reduction in DAS for PTT at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 27

28.  Secondary:   Percentage of Subjects With at Least One Grade Reduction in DAS for Individual Domains at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 28

29.  Secondary:   Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Extrinsic Finger Flexors as PTMG   [ Time Frame: At Week 4 ]
  Show Outcome Measure 29

30.  Secondary:   Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Extrinsic Finger Flexors as PTMG   [ Time Frame: At Week 4 ]
  Show Outcome Measure 30

31.  Secondary:   Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Elbow Flexors as PTMG   [ Time Frame: At Week 4 ]
  Show Outcome Measure 31

32.  Secondary:   Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Elbow Flexors as PTMG   [ Time Frame: At Week 4 ]
  Show Outcome Measure 32

33.  Secondary:   Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Wrist Flexors as PTMG   [ Time Frame: At Week 4 ]
  Show Outcome Measure 33

34.  Secondary:   Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Wrist Flexors as PTMG   [ Time Frame: At Week 4 ]
  Show Outcome Measure 34

35.  Secondary:   Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Shoulder Extensors   [ Time Frame: At Week 4 ]
  Show Outcome Measure 35

36.  Secondary:   Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Shoulder Extensors   [ Time Frame: At Week 4 ]
  Show Outcome Measure 36

37.  Secondary:   Mean Change From Baseline in Active Range of Motion (AROM) at Week 4 in the 3 Possible PTMGs   [ Time Frame: At Week 4 ]
  Show Outcome Measure 37

38.  Secondary:   Mean Change From Baseline at Week 4 in Ease of Applying a Splint   [ Time Frame: At Week 4 ]
  Show Outcome Measure 38

39.  Secondary:   Mean Change From Baseline in Modified Frenchay Scale (MFS) at Week 4   [ Time Frame: At Week 4 ]
  Show Outcome Measure 39

40.  Secondary:   Mean Change From Baseline in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) at End of Study/Early Withdrawal Visit   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 40

41.  Secondary:   Mean Change From Baseline in European 5 Dimensions, 5 Level (EQ-5D-5L) QoL at End of Study/Early Withdrawal Visit   [ Time Frame: Up to Week 52 ]
  Show Outcome Measure 41


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Medical Director, Neurology.
Organization: Ipsen Innovation
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01313312     History of Changes
Other Study ID Numbers: Y-52-52120-148
2010-019162-83 ( EudraCT Number )
First Submitted: March 10, 2011
First Posted: March 11, 2011
Results First Submitted: March 1, 2017
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017