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Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

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: NCT00447772
Recruitment Status : Completed
First Posted : March 15, 2007
Results First Posted : July 30, 2018
Last Update Posted : January 14, 2019
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 Cervical Dystonia
Intervention Drug: Botulinum type A toxin (Dysport®)
Enrollment 516
Recruitment Details First patient enrolled (signed informed consent) 28 Oct 2004, last patient completed 4 April 2008. 516 patients were recruited to this prospective, open, multicentre study at 77 study centres in Germany and 4 study centres in Austria.
Pre-assignment Details To be eligible patients had to have 2 of the most frequent forms of cervical dystonia (CD): rotatory torticollis or laterocollis.
Arm/Group Title Dysport® 500 U - Total Study Population
Hide Arm/Group Description

Patients with heterogeneous forms of CD were given a single intramuscular (i.m.) injection of 500 units (U) Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 millilitres (ml) 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Period Title: Overall Study
Started 516
Completed 489
Not Completed 27
Reason Not Completed
Lack of Efficacy             3
Insufficient compliance             6
Discontinuation of drug therapy             1
Lost to Follow-up             9
Withdrawal by Subject             1
Unable to attend all study visits             2
Adverse Event             1
Patient relocated             1
Incomplete documentation at visit 1             1
Chemotherapy for lung cancer             1
Premature re-injection required             1
Arm/Group Title Dysport® 500 U - Total Study Population
Hide Arm/Group Description

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Baseline Participants 515
Hide Baseline Analysis Population Description
Baseline characteristics are reported for the Safety Population which included all patients who received the study medication and for who any safety data were recorded. All 516 patients who were enrolled received study medication. However, for one patient no safety data were available for analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 515 participants
51.9  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants
Female
353
  68.5%
Male
162
  31.5%
1.Primary Outcome
Title Change From Baseline in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) at the First On-treatment Visit (Week 4 or Week 12)
Hide Description

The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:

  • Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0–9 points)
  • Subscore B: duration of movement (values 1 or 2)
  • Subscore C: severity and duration of shoulder elevation (range: 0–3 points)
  • Subscore D: severity and duration of tremor (range: 0–4 points).

The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.

The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the first on-treatment visit (Week 4 or Week 12 visit) is presented.

Time Frame Baseline to Week 4 or Week 12 (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention to Treat (ITT) Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale.
Arm/Group Title Rotatory Torticollis Laterocollis Dysport® 500 U - Total Study Population
Hide Arm/Group Description:
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 396 107 503
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.8  (3.3) -4.0  (2.6) -3.8  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotatory Torticollis, Laterocollis
Comments An analysis of covariance (ANCOVA) model included the baseline total Tsui score (patient in sitting position) as covariate and the main type of CD as between-group factor (due to non-significance the interaction between baseline total Tsui score and the main type of CD was removed from the model).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.2552
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference
Estimated Value -0.322
Confidence Interval (2-Sided) 95%
-0.877 to 0.233
Estimation Comments The comparative analysis is based on adjusted means data.
2.Secondary Outcome
Title Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12)
Hide Description

The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:

  • Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0–9 points)
  • Subscore B: duration of movement (values 1 or 2)
  • Subscore C: severity and duration of shoulder elevation (range: 0–3 points)
  • Subscore D: severity and duration of tremor (range: 0–4 points).

The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.

The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 12 visit is presented.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for the Week 12 visit are reported.
Arm/Group Title Rotatory Torticollis Laterocollis Dysport® 500 U - Total Study Population
Hide Arm/Group Description:
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 386 104 490
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.3  (3.4) -2.4  (2.5) -2.3  (3.2)
3.Secondary Outcome
Title Change in the Total Score of the Tsui Rating Scale (Patient Walking) Between Baseline (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Hide Description

The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:

  • Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0–9 points)
  • Subscore B: duration of movement (values 1 or 2)
  • Subscore C: severity and duration of shoulder elevation (range: 0–3 points)
  • Subscore D: severity and duration of tremor (range: 0–4 points).

The total score was calculated as follows: total score = subscores (A x B) + C + D.

The total score ranges between 0 and 25 points. A high total score represents severe CD.

The mean changes in the total score of the Tsui rating scale (patient walking) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.

Time Frame Baseline to Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
Arm/Group Title Rotatory Torticollis Laterocollis Dysport® 500 U - Total Study Population
Hide Arm/Group Description:
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 396 107 503
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change to Week 4 in total Tsui score Number Analyzed 294 participants 77 participants 371 participants
-3.8  (3.2) -4.3  (2.9) -3.9  (3.2)
Change to Week 12 in total Tsui score Number Analyzed 285 participants 79 participants 364 participants
-2.3  (3.6) -2.3  (3.1) -2.3  (3.5)
4.Secondary Outcome
Title Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Hide Description

The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:

  • Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0–9 points)
  • Subscore B: duration of movement (values 1 or 2)
  • Subscore C: severity and duration of shoulder elevation (range: 0–3 points)
  • Subscore D: severity and duration of tremor (range: 0–4 points).

A higher score for each subscale represents severe CD symptoms. The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.

The mean changes in the subscores A to D of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.

Time Frame Baseline to Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
Arm/Group Title Rotatory Torticollis Laterocollis Dysport® 500 U - Total Study Population
Hide Arm/Group Description:
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 396 107 503
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change to Week 4 in Tsui rating scale subscore A Number Analyzed 394 participants 106 participants 500 participants
-1.3  (1.3) -1.5  (1.2) -1.4  (1.3)
Change to Week 4 in Tsui rating scale subscore B Number Analyzed 394 participants 106 participants 500 participants
-0.4  (0.6) -0.3  (0.5) -0.3  (0.6)
Chang to Week 4 in Tsui rating scale subscore C Number Analyzed 394 participants 106 participants 500 participants
-0.4  (0.8) -0.6  (0.8) -0.4  (0.8)
Change to Week 4 in Tsui rating scale subscore D Number Analyzed 394 participants 106 participants 500 participants
-0.6  (1.0) -0.5  (1.0) -0.6  (1.0)
Change to Week 12 in Tsui rating scale subscore A Number Analyzed 386 participants 104 participants 490 participants
-0.8  (1.3) -0.9  (1.2) -0.8  (1.3)
Change to Week 12 in Tsui rating scale subscore B Number Analyzed 386 participants 104 participants 490 participants
-0.2  (0.5) -0.1  (0.4) -0.2  (0.5)
Change to Week 12 in Tsui rating scale subscore C Number Analyzed 386 participants 104 participants 490 participants
-0.2  (0.8) -0.3  (0.7) -0.2  (0.8)
Change to Week 12 in Tsui rating scale subscore D Number Analyzed 386 participants 104 participants 490 participants
-0.4  (0.9) -0.3  (0.9) -0.4  (0.9)
5.Secondary Outcome
Title Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Hide Description

The CDQ-24 is a disease-specific quality of life (QoL) instrument and was assessed at Visits 1 to 3. It consists of 24 items investigating problems in daily living skills related to CD.

This instrument is based on 5 subscales: Stigma, Emotional well-being, Pain, Activities of daily living (ADL), Social/family life to which a number of the 24 items are assigned. There are five possible answers to each item representing increasing severity of impairment (scores 0 to 4). The total scores ranged from 0 to 96 (best to worst QoL). In order to obtain scores of the individual subscales, the total score of each subscale (sum of the individual item scores) was transformed linearly to a 0 to 100 scale (best to worst QoL).

The mean changes in the CDQ-24 total score between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.

Time Frame Baseline to Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
Arm/Group Title Dysport® 500 U - Total Study Population
Hide Arm/Group Description:

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 503
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change to Week 4 in CDQ-24 total score Number Analyzed 484 participants
-11.1  (16.1)
Change to Week 4 in CDQ-24 Stigma subscale Number Analyzed 485 participants
-16.8  (24.0)
Change to Week 4 in CDQ-24 Emotional subscale Number Analyzed 485 participants
-10.3  (19.9)
Change to Week 4 in CDQ-24 Pain subscale Number Analyzed 491 participants
-11.5  (27.8)
Change to Week 4 in CDQ-24 ADL subscale Number Analyzed 483 participants
-11.1  (19.6)
Change to Week 4 in CDQ-24 Social subscale Number Analyzed 481 participants
-5.6  (17.9)
Change to Week 12 in CDQ-24 total score Number Analyzed 474 participants
-11.8  (14.6)
Change to Week 12 in CDQ-24 Stigma subscale Number Analyzed 476 participants
-16.4  (22.5)
Change to Week 12 in CDQ-24 Emotional subscale Number Analyzed 476 participants
-11.1  (18.7)
Change to Week 12 in CDQ-24 Pain subscale Number Analyzed 484 participants
-13.2  (25.5)
Change to Week 12 in CDQ-24 ADL subscale Number Analyzed 474 participants
-12.5  (18.6)
Change to Week 12 in CDQ-24 Social life subscale Number Analyzed 469 participants
-6.7  (17.8)
6.Secondary Outcome
Title Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Hide Description

The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question).

The mean changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.

Time Frame Baseline to Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
Arm/Group Title Dysport® 500 U - Total Study Population
Hide Arm/Group Description:

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 503
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change to Week 4 in Day-to-day functions Number Analyzed 454 participants
-1.1  (3.0)
Change to Week 4 in Pain Number Analyzed 452 participants
-0.8  (2.7)
Change to Week 4 in Duration of pain Number Analyzed 451 participants
-1.2  (2.9)
Change to Week 12 in Day-to-day functions Number Analyzed 384 participants
-1.1  (2.6)
Change to Week 12 in Pain Number Analyzed 383 participants
-0.9  (2.5)
Change to Week 12 in Duration of pain Number Analyzed 382 participants
-1.3  (2.7)
7.Secondary Outcome
Title Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Hide Description

The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question).

The following categorical changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented: Improvement, No change and Deterioration.

Time Frame Baseline to Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
Arm/Group Title Dysport® 500 U - Total Study Population
Hide Arm/Group Description:

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 503
Measure Type: Number
Unit of Measure: percentage of patients
Improvement in Day-to-day functions to Week 4 Number Analyzed 454 participants
59.9
No change in Day-to-day functions to Week 4 Number Analyzed 454 participants
19.6
Deterioration in Day-to-day functions to Week 4 Number Analyzed 454 participants
20.5
Improvement in Pain to Week 4 Number Analyzed 452 participants
50.2
No change in Pain to Week 4 Number Analyzed 452 participants
23.0
Deterioration in Pain to Week 4 Number Analyzed 452 participants
26.8
Improvement in Duration in pain to Week 4 Number Analyzed 451 participants
52.3
No change in Duration of pain to Week 4 Number Analyzed 451 participants
24.6
Deterioration in Duration of pain to Week 4 Number Analyzed 451 participants
23.1
Improvement in Day-to-day functions to Week 12 Number Analyzed 384 participants
55.2
No change in Day-to-day functions to Week 12 Number Analyzed 384 participants
22.9
Deterioration in Day-to-day functions to Week 12 Number Analyzed 384 participants
21.9
Improvement in Pain to Week 12 Number Analyzed 383 participants
48.3
No change in Pain to Week 12 Number Analyzed 383 participants
25.1
Deterioration in Pain to Week 12 Number Analyzed 383 participants
26.6
Improvement in Duration of pain to Week 12 Number Analyzed 382 participants
55.2
No change in Duration of pain to Week 12 Number Analyzed 382 participants
24.3
Deterioration in Duration of pain to Week 12 Number Analyzed 382 participants
20.4
8.Secondary Outcome
Title Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Hide Description

Global pain was assessed at Visit 2 (Week 4) and Visit 3 (Week 12); investigators and patients assessed change in global pain according to the following response categories:

  1. = no pain (anymore)
  2. = less pain
  3. = no change
  4. = more pain

The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.

Time Frame Week 4 visit and Week 12 visit
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
Arm/Group Title Dysport® 500 U - Total Study Population
Hide Arm/Group Description:

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 503
Measure Type: Number
Unit of Measure: Participants
No pain at Week 4 (Investigator assessment) Number Analyzed 500 participants
131
Less pain at Week 4 (Investigator assessment) Number Analyzed 500 participants
205
No change at Week 4 (Investigator assessment) Number Analyzed 500 participants
94
More pain at Week 4 (Investigator assessment) Number Analyzed 500 participants
70
No pain at Week 12 (Investigator assessment) Number Analyzed 489 participants
142
Less pain at Week 12 (Investigator assessment) Number Analyzed 489 participants
227
No change at Week 12 (Investigator assessment) Number Analyzed 489 participants
87
More pain at Week 12 (Investigator assessment) Number Analyzed 489 participants
33
No pain at Week 4 (Patient assessment) Number Analyzed 500 participants
128
Less pain at Week 4 (Patient assessment) Number Analyzed 500 participants
202
No change at Week 4 (Patient assessment) Number Analyzed 500 participants
82
More pain at Week 4 (Patient assessment) Number Analyzed 500 participants
88
No pain at Week 12 (Patient assessment) Number Analyzed 490 participants
132
Less pain at Week 12 (Patient assessment) Number Analyzed 490 participants
231
No change at Week 12 (Patient assessment) Number Analyzed 490 participants
83
More pain at Week 12 (Patient assessment) Number Analyzed 490 participants
44
9.Secondary Outcome
Title Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Hide Description

At Visit 2 (Week 4) and Visit 3 (Week 12) investigators and patients assessed global efficacy of injection of 500 U Dysport® according to the following response categories:

  1. = very good
  2. = good
  3. = moderate
  4. = insufficient

The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.

Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
Arm/Group Title Dysport® 500 U - Total Study Population
Hide Arm/Group Description:

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

Overall Number of Participants Analyzed 503
Measure Type: Number
Unit of Measure: Participants
Week 4 (Investigator assessment): Very good Number Analyzed 500 participants
129
Week 4 (Investigator assessment): Good Number Analyzed 500 participants
221
Week 4 (Investigator assessment): Moderate Number Analyzed 500 participants
109
Week 4 (Investigator assessment): Insufficient Number Analyzed 500 participants
41
Week 12 (Investigator assessment): Very good Number Analyzed 489 participants
134
Week 12 (Investigator assessment): Good Number Analyzed 489 participants
218
Week 12 (Investigator assessment): Moderate Number Analyzed 489 participants
102
Week 12 (Investigator assessment): Insufficient Number Analyzed 489 participants
35
Week 4 (Patient assessment): Very good Number Analyzed 500 participants
97
Week 4 (Patient assessment): Good Number Analyzed 500 participants
207
Week 4 (Patient assessment): Moderate Number Analyzed 500 participants
113
Week 4 (Patient assessment): Insufficient Number Analyzed 500 participants
83
Week 12 (Patient assessment): Very good Number Analyzed 490 participants
113
Week 12 (Patient assessment): Good Number Analyzed 490 participants
205
Week 12 (Patient assessment): Moderate Number Analyzed 490 participants
100
Week 12 (Patient assessment): Insufficient Number Analyzed 490 participants
72
Time Frame From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
Adverse Event Reporting Description All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
 
Arm/Group Title Dysport® 500 U - Total Study Population
Hide Arm/Group Description

Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.

The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.

All-Cause Mortality
Dysport® 500 U - Total Study Population
Affected / at Risk (%)
Total   0/515 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dysport® 500 U - Total Study Population
Affected / at Risk (%) # Events
Total   11/515 (2.14%)    
Cardiac disorders   
Bradycardia  1  1/515 (0.19%)  1
Myocardial infarction  1  1/515 (0.19%)  1
Cardiac failure  1  1/515 (0.19%)  1
Coronary artery disease  1  1/515 (0.19%)  1
Eye disorders   
Blindness  1  1/515 (0.19%)  1
Gastrointestinal disorders   
Peritonitis  1  1/515 (0.19%)  1
Infections and infestations   
Appendicitis  1  1/515 (0.19%)  1
Pneumonia  1  1/515 (0.19%)  1
Injury, poisoning and procedural complications   
Ankle fracture  1  1/515 (0.19%)  1
Fall  1  1/515 (0.19%)  1
Femur fracture  1  1/515 (0.19%)  1
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  2/515 (0.39%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung adenocarcinoma  1  1/515 (0.19%)  1
Nervous system disorders   
Syncope  1  1/515 (0.19%)  1
Psychiatric disorders   
Depression  1  2/515 (0.39%)  2
Apathy  1  1/515 (0.19%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary congestion  1  1/515 (0.19%)  1
1
Term from vocabulary, MedDRA 9.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dysport® 500 U - Total Study Population
Affected / at Risk (%) # Events
Total   206/515 (40.00%)    
Cardiac disorders   
Angina pectoris  1  1/515 (0.19%)  1
Coronary artery disease  1  1/515 (0.19%)  1
Tachycardia  1  1/515 (0.19%)  1
Ear and labyrinth disorders   
Sudden hearing loss  1  1/515 (0.19%)  1
Tinnitus  1  3/515 (0.58%)  3
Vertigo  1  4/515 (0.78%)  5
Endocrine disorders   
Goitre  1  1/515 (0.19%)  1
Eye disorders   
Blepharitis  1  1/515 (0.19%)  1
Dry eye  1  2/515 (0.39%)  2
Eyelid ptosis  1  1/515 (0.19%)  1
Glaucoma  1  1/515 (0.19%)  1
Keratoconjunctivitis sicca  1  1/515 (0.19%)  1
Vision blurred  1  2/515 (0.39%)  2
Gastrointestinal disorders   
Abdominal discomfort  1  1/515 (0.19%)  1
Abdominal pain upper  1  3/515 (0.58%)  3
Constipation  1  1/515 (0.19%)  1
Dental caries  1  1/515 (0.19%)  1
Diarrhoea  1  4/515 (0.78%)  4
Dry mouth  1  6/515 (1.17%)  6
Dysphagia  1  51/515 (9.90%)  51
Gastritis  1  2/515 (0.39%)  2
Gastrointestinal pain  1  1/515 (0.19%)  1
Nausea  1  3/515 (0.58%)  3
Toothache  1  1/515 (0.19%)  1
Vomiting  1  1/515 (0.19%)  1
General disorders   
Asthenia  1  3/515 (0.58%)  3
Facial pain  1  1/515 (0.19%)  1
Fatigue  1  6/515 (1.17%)  6
Gait disturbance  1  1/515 (0.19%)  1
General physical health deterioration  1  1/515 (0.19%)  1
Influenza like illness  1  2/515 (0.39%)  2
Injection site pain  1  7/515 (1.36%)  7
Injection site paraesthesia  1  1/515 (0.19%)  1
Local swelling  1  2/515 (0.39%)  2
Malaise  1  1/515 (0.19%)  1
Oedema peripheral  1  1/515 (0.19%)  1
Sensation of foreign body  1  1/515 (0.19%)  1
Thirst  1  1/515 (0.19%)  1
Infections and infestations   
Acute tonsillitis  1  1/515 (0.19%)  1
Bronchitis  1  2/515 (0.39%)  2
Cystitis  1  3/515 (0.58%)  3
Device related infection  1  1/515 (0.19%)  1
Eye infection viral  1  1/515 (0.19%)  1
Herpes simplex  1  1/515 (0.19%)  1
Herpes zoster  1  2/515 (0.39%)  2
Hordeolum  1  2/515 (0.39%)  2
Laryngitis  1  3/515 (0.58%)  4
Nasopharyngitis  1  19/515 (3.69%)  20
Otitis media  1  1/515 (0.19%)  1
Pneumonia bacterial  1  1/515 (0.19%)  1
Respiratory tract infection  1  1/515 (0.19%)  1
Rhinitis  1  1/515 (0.19%)  2
Sinusitis  1  1/515 (0.19%)  1
Upper respiratory tract infection  1  1/515 (0.19%)  1
Vulvovaginal mycotic infection  1  1/515 (0.19%)  1
Investigations   
Blood pressure diastolic increased  1  1/515 (0.19%)  1
Blood pressure increased  1  2/515 (0.39%)  2
Blood pressure orthostatic abnormal  1  1/515 (0.19%)  1
Metabolism and nutrition disorders   
Hypercholesterolaemia  1  1/515 (0.19%)  1
Hypokalaemia  1  1/515 (0.19%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  5/515 (0.97%)  5
Arthritis  1  1/515 (0.19%)  1
Back pain  1  8/515 (1.55%)  8
Bursitis  1  1/515 (0.19%)  1
Joint range of motion decreased  1  2/515 (0.39%)  2
Joint stiffness  1  1/515 (0.19%)  1
Muscle spasms  1  1/515 (0.19%)  1
Muscular weakness  1  70/515 (13.59%)  70
Musculoskeletal discomfort  1  1/515 (0.19%)  1
Musculoskeletal disorder  1  2/515 (0.39%)  2
Musculoskeletal pain  1  9/515 (1.75%)  12
Musculoskeletal stiffness  1  5/515 (0.97%)  5
Myalgia  1  8/515 (1.55%)  9
Neck pain  1  34/515 (6.60%)  35
Osteoarthritis  1  1/515 (0.19%)  2
Pain in extremity  1  3/515 (0.58%)  4
Pain in jaw  1  1/515 (0.19%)  1
Trismus  1  1/515 (0.19%)  1
Nervous system disorders   
Burning sensation  1  4/515 (0.78%)  4
Cervical root pain  1  1/515 (0.19%)  1
Disturbance in attention  1  1/515 (0.19%)  1
Dizziness  1  12/515 (2.33%)  13
Dysarthria  1  4/515 (0.78%)  4
Head discomfort  1  2/515 (0.39%)  2
Head titubation  1  1/515 (0.19%)  2
Headache  1  17/515 (3.30%)  21
Hypoaesthesia  1  1/515 (0.19%)  1
Mastication disorder  1  1/515 (0.19%)  1
Migraine  1  1/515 (0.19%)  1
Neuritis  1  1/515 (0.19%)  1
Paraesthesia  1  4/515 (0.78%)  4
Paralysis  1  1/515 (0.19%)  1
Paresis  1  1/515 (0.19%)  1
Restless legs syndrome  1  1/515 (0.19%)  1
Speech disorder  1  2/515 (0.39%)  2
Tongue paralysis  1  1/515 (0.19%)  1
Tremor  1  2/515 (0.39%)  2
Psychiatric disorders   
Anxiety  1  1/515 (0.19%)  1
Anxiety disorder  1  1/515 (0.19%)  1
Conversion disorder  1  2/515 (0.39%)  2
Depression  1  2/515 (0.39%)  2
Initial insomnia  1  1/515 (0.19%)  1
Middle insomnia  1  1/515 (0.19%)  1
Panic attack  1  2/515 (0.39%)  2
Psychotic disorder  1  1/515 (0.19%)  1
Restlessness  1  1/515 (0.19%)  1
Renal and urinary disorders   
Dysuria  1  1/515 (0.19%)  1
Haematuria  1  1/515 (0.19%)  1
Nephritis  1  1/515 (0.19%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/515 (0.19%)  1
Cough  1  2/515 (0.39%)  2
Dyspnoea  1  2/515 (0.39%)  2
Rhinitis allergic  1  1/515 (0.19%)  1
Throat irritation  1  1/515 (0.19%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/515 (0.19%)  1
Eczema  1  1/515 (0.19%)  2
Hyperhidrosis  1  3/515 (0.58%)  3
Pruritus  1  1/515 (0.19%)  1
Pruritus generalised  1  1/515 (0.19%)  1
Rash  1  2/515 (0.39%)  3
Urticaria  1  1/515 (0.19%)  1
Surgical and medical procedures   
Limb operation  1  1/515 (0.19%)  1
Vascular disorders   
Circulatory collapse  1  2/515 (0.39%)  2
Hypertension  1  4/515 (0.78%)  4
Orthostatic hypotension  1  1/515 (0.19%)  1
Thrombophlebitis  1  1/515 (0.19%)  1
1
Term from vocabulary, MedDRA 9.1
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Medical Director, Neurology
Organization: Ipsen
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00447772     History of Changes
Other Study ID Numbers: A-94-52120-098
First Submitted: March 13, 2007
First Posted: March 15, 2007
Results First Submitted: May 9, 2017
Results First Posted: July 30, 2018
Last Update Posted: January 14, 2019