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Dysport® Adult Upper Limb Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01313299
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : October 23, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nervous System Disorders
Interventions Drug: Botulinum type A toxin (Dysport®)
Drug: Placebo
Enrollment 243
Recruitment Details This multicenter study was conducted in 34 investigational sites. Subjects screened were 281 and randomised and treated were 243.
Pre-assignment Details  
Arm/Group Title Placebo Dysport 500 U Dysport 1000 U
Hide Arm/Group Description Placebo intramuscular injection single treatment cycle on day 1 Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1 Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
Period Title: Overall Study
Started 81 81 81
Completed 74 78 77
Not Completed 7 3 4
Reason Not Completed
Adverse Event             3             1             1
Lost to Follow-up             1             0             0
Protocol Violation             2             0             0
Withdrawal by Subject             1             0             2
Family reason and moved out of state             0             2             0
Lack of subject compliance             0             0             1
Arm/Group Title Placebo Dysport 500 U Dysport 1000 U Total
Hide Arm/Group Description Placebo intramuscular injection single treatment cycle on day 1 Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1 Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1 Total of all reporting groups
Overall Number of Baseline Participants 81 81 81 243
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 81 participants 81 participants 243 participants
52.9  (13.8) 52.8  (12.8) 53.2  (13.8) 52.9  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 81 participants 81 participants 243 participants
Female
31
  38.3%
28
  34.6%
28
  34.6%
87
  35.8%
Male
50
  61.7%
53
  65.4%
53
  65.4%
156
  64.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants 81 participants 81 participants 243 participants
Asian 1 3 2 6
Black/African American 9 7 11 27
Caucasian/White 71 70 67 208
Multiple 0 1 1 2
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants 81 participants 81 participants 243 participants
Hispanic/Latino 5 3 10 18
Not Hispanic/Latino 76 78 71 225
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 81 participants 81 participants 81 participants 243 participants
26.78  (5.38) 27.63  (4.61) 27.58  (5.51) 27.33  (5.17)
[1]
Measure Description: Placebo: N=78, Dysport 500 U: N=80, and Dysport 1000 U: N=80.
Modified Ashworth Scale (MAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 81 participants 81 participants 81 participants 243 participants
3.9  (0.4) 3.9  (0.5) 3.9  (0.4) 3.9  (0.4)
[1]
Measure Description:

MAS scale is used to assess muscle tone (MT) using a 6-point scale where:0=No increase in MT, 1=Slight increase in MT,1±=Slight increase in MT manifested by a catch followed by minimal resistance throughout remainder of ROM,2=Marked increase in MT through most of ROM but affected part easily moved,3=Considerable increase in MT passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.

Placebo:N=79, Dysport 500U:N=80 & Dysport 1000U:N=79.

Disability Assessment Scale (DAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 81 participants 81 participants 81 participants 243 participants
2.6  (0.5) 2.6  (0.5) 2.5  (0.5) 2.6  (0.5)
[1]
Measure Description:

DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited). If the subject chose Hygiene as PTT the score collected will be between 0 and 3.

Placebo: N=79, Dysport 500 U: N=80 and Dysport 1000 U: N=79.

1.Primary Outcome
Title Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)
Hide Description MAS scale is used to assess muscle tone using a 6-point scale where: 0=No increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.
Time Frame From Baseline (Day 1) to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4.
Arm/Group Title Placebo Dysport 500 U Dysport 1000 U
Hide Arm/Group Description:
Placebo intramuscular injection single treatment cycle on day 1
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
Overall Number of Participants Analyzed 79 80 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (0.6) -1.2  (1.0) -1.4  (1.1)
2.Secondary Outcome
Title Physician's Global Assessment (PGA) of Treatment Response
Hide Description PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved).
Time Frame At Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4
Arm/Group Title Placebo Dysport 500 U Dysport 1000 U
Hide Arm/Group Description:
Placebo intramuscular injection single treatment cycle on day 1
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
Overall Number of Participants Analyzed 78 80 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (1.0) 1.4  (1.1) 1.8  (1.1)
3.Secondary Outcome
Title Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)
Hide Description

DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited).

If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3.

Time Frame From Baseline (Day 1) to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Two subjects each from Placebo and Dysport 1000 U had missed DAS assessment at baseline and week 4.
Arm/Group Title Placebo Dysport 500 U Dysport 1000 U
Hide Arm/Group Description:
Placebo intramuscular injection single treatment cycle on day 1
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
Overall Number of Participants Analyzed 79 80 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (0.7) -0.7  (0.8) -0.7  (0.7)
Time Frame Up to 24±2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Dysport 500 U Dysport 1000 U
Hide Arm/Group Description Placebo intramuscular injection single treatment cycle on day 1 Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1 Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
All-Cause Mortality
Placebo Dysport 500 U Dysport 1000 U
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dysport 500 U Dysport 1000 U
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/81 (3.70%)      3/81 (3.70%)      3/81 (3.70%)    
Cardiac disorders       
Cardiovascular disorder  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0
General disorders       
Death  1 [1]  1/81 (1.23%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Infections and infestations       
Sepsis  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0
Injury, poisoning and procedural complications       
Ligament sprain  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1
Craniocerebral injury  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle spasms  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0
Muscular weakness  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1
Partial seizures  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1
Syncope  1  0/81 (0.00%)  0 0/81 (0.00%)  0 1/81 (1.23%)  1
Respiratory, thoracic and mediastinal disorders       
Pulmonary oedema  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Vascular disorders       
Behcet's syndrome  1  0/81 (0.00%)  0 1/81 (1.23%)  1 0/81 (0.00%)  0
Deep vein thrombosis  1  1/81 (1.23%)  1 0/81 (0.00%)  0 0/81 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
[1]
General disorders and administration site conditions
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Dysport 500 U Dysport 1000 U
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/81 (12.35%)      25/81 (30.86%)      18/81 (22.22%)    
Gastrointestinal disorders       
Diarrhoea  2  0/81 (0.00%)  0 2/81 (2.47%)  2 1/81 (1.23%)  1
Nausea  2  0/81 (0.00%)  0 3/81 (3.70%)  3 0/81 (0.00%)  0
General disorders       
Injection site erythema  2  0/81 (0.00%)  0 0/81 (0.00%)  0 2/81 (2.47%)  2
Injection site bruising  2  2/81 (2.47%)  2 1/81 (1.23%)  1 1/81 (1.23%)  1
Asthenia  2  1/81 (1.23%)  1 2/81 (2.47%)  2 0/81 (0.00%)  0
Injection site pain  2  3/81 (3.70%)  3 1/81 (1.23%)  1 0/81 (0.00%)  0
Infections and infestations       
Nasopharyngitis  1  1/81 (1.23%)  1 7/81 (8.64%)  7 1/81 (1.23%)  1
Sinusitis  2  0/81 (0.00%)  0 2/81 (2.47%)  2 1/81 (1.23%)  1
Urinary tract infections  2  0/81 (0.00%)  0 2/81 (2.47%)  2 1/81 (1.23%)  1
Injury, poisoning and procedural complications       
Fall  2  0/81 (0.00%)  0 1/81 (1.23%)  1 2/81 (2.47%)  2
Investigations       
Gamma glutamyl transferase increased  2  0/81 (0.00%)  0 2/81 (2.47%)  2 2/81 (2.47%)  2
Blood triglycerides increased  2  0/81 (0.00%)  0 3/81 (3.70%)  3 1/81 (1.23%)  1
Blood pressure increased  2  0/81 (0.00%)  0 1/81 (1.23%)  1 2/81 (2.47%)  2
Blood glucose increased  2  0/81 (0.00%)  0 2/81 (2.47%)  2 0/81 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscular Weakness  2  1/81 (1.23%)  1 2/81 (2.47%)  2 4/81 (4.94%)  4
Back pain  2  1/81 (1.23%)  1 0/81 (0.00%)  0 2/81 (2.47%)  2
Arthralgia  2  1/81 (1.23%)  1 2/81 (2.47%)  4 1/81 (1.23%)  1
Musculoskeletal pain  2  1/81 (1.23%)  1 2/81 (2.47%)  2 1/81 (1.23%)  1
Nervous system disorders       
Headache  2  0/81 (0.00%)  0 1/81 (1.23%)  1 2/81 (2.47%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  2  0/81 (0.00%)  0 2/81 (2.47%)  3 1/81 (1.23%)  1
Epistaxis  2  0/81 (0.00%)  0 2/81 (2.47%)  3 0/81 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
2
Term from vocabulary, MedDRA 16.0
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
Phone: clinical.trials@ipsen.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01313299     History of Changes
Other Study ID Numbers: Y-52-52120-145
2010-019069-28 ( EudraCT Number )
First Submitted: March 10, 2011
First Posted: March 11, 2011
Results First Submitted: August 11, 2015
Results First Posted: October 23, 2015
Last Update Posted: March 7, 2017