Cervical Dystonia
Conditions
Keywords
Dysport, Cervical Dystonia
Brief summary
The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.
Interventions
BIOLOGICALBotulinum toxin type A
Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* De novo patients with cervical dystonia * Outpatient * Patients to be of age 18 years or older * Written informed consent to participate in the study
Exclusion criteria
* Pre-treatment of cervical dystonia with botulinum toxin * Pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months * Pure retro- or antecollis * Neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, Bekhterev's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline to Week 4 or Week 12 (up to 12 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline to Week 4 and Week 12 | 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. |
| 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) | Baseline to Week 4 and Week 12 | 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. |
| 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) | Baseline to Week 4 and Week 12 | 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. |
| Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12) | Baseline to Week 12 | 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. |
| 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) | Baseline to Week 4 and Week 12 | 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. |
| 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) | Week 4 visit and Week 12 visit | 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. |
| Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 and Week 12 | 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. |
| 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) | Baseline to Week 4 and Week 12 | 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. |
Countries
Austria, Germany
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Dysport® 500 U - Total Study Population 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. | 515 |
| Total | 515 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Chemotherapy for lung cancer | 1 |
| Overall Study | Discontinuation of drug therapy | 1 |
| Overall Study | Incomplete documentation at visit 1 | 1 |
| Overall Study | Insufficient compliance | 6 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Patient relocated | 1 |
| Overall Study | Premature re-injection required | 1 |
| Overall Study | Unable to attend all study visits | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Dysport® 500 U - Total Study Population |
|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 353 Participants |
| Sex: Female, Male Male | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 515 |
| other Total, other adverse events | 206 / 515 |
| serious Total, serious adverse events | 11 / 515 |
Outcome results
Primary
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)
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)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotatory Torticollis | 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) | -3.8 units on a scale | Standard Deviation 3.3 |
| Laterocollis | 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) | -4.0 units on a scale | Standard Deviation 2.6 |
| Dysport® 500 U - Total Study Population | 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) | -3.8 units on a scale | Standard Deviation 3.1 |
Comparison: 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).p-value: =0.255295% CI: [-0.877, 0.233]ANCOVA
Secondary
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)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotatory Torticollis | 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) | Improvement in Day-to-day functions to Week 4 | 59.9 percentage of patients |
| Rotatory Torticollis | 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) | No change in Day-to-day functions to Week 4 | 19.6 percentage of patients |
| Rotatory Torticollis | 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) | Deterioration in Day-to-day functions to Week 4 | 20.5 percentage of patients |
| Rotatory Torticollis | 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) | Improvement in Pain to Week 4 | 50.2 percentage of patients |
| Rotatory Torticollis | 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) | No change in Pain to Week 4 | 23.0 percentage of patients |
| Rotatory Torticollis | 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) | Deterioration in Pain to Week 4 | 26.8 percentage of patients |
| Rotatory Torticollis | 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) | Improvement in Duration in pain to Week 4 | 52.3 percentage of patients |
| Rotatory Torticollis | 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) | No change in Duration of pain to Week 4 | 24.6 percentage of patients |
| Rotatory Torticollis | 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) | Deterioration in Duration of pain to Week 4 | 23.1 percentage of patients |
| Rotatory Torticollis | 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) | Improvement in Day-to-day functions to Week 12 | 55.2 percentage of patients |
| Rotatory Torticollis | 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) | No change in Day-to-day functions to Week 12 | 22.9 percentage of patients |
| Rotatory Torticollis | 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) | Deterioration in Day-to-day functions to Week 12 | 21.9 percentage of patients |
| Rotatory Torticollis | 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) | Improvement in Pain to Week 12 | 48.3 percentage of patients |
| Rotatory Torticollis | 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) | No change in Pain to Week 12 | 25.1 percentage of patients |
| Rotatory Torticollis | 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) | Deterioration in Pain to Week 12 | 26.6 percentage of patients |
| Rotatory Torticollis | 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) | Improvement in Duration of pain to Week 12 | 55.2 percentage of patients |
| Rotatory Torticollis | 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) | No change in Duration of pain to Week 12 | 24.3 percentage of patients |
| Rotatory Torticollis | 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) | Deterioration in Duration of pain to Week 12 | 20.4 percentage of patients |
Secondary
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)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotatory Torticollis | 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) | Change to Week 4 in Tsui rating scale subscore A | -1.3 units on a scale | Standard Deviation 1.3 |
| Rotatory Torticollis | 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) | Change to Week 4 in Tsui rating scale subscore B | -0.4 units on a scale | Standard Deviation 0.6 |
| Rotatory Torticollis | 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) | Chang to Week 4 in Tsui rating scale subscore C | -0.4 units on a scale | Standard Deviation 0.8 |
| Rotatory Torticollis | 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) | Change to Week 4 in Tsui rating scale subscore D | -0.6 units on a scale | Standard Deviation 1 |
| Rotatory Torticollis | 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) | Change to Week 12 in Tsui rating scale subscore A | -0.8 units on a scale | Standard Deviation 1.3 |
| Rotatory Torticollis | 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) | Change to Week 12 in Tsui rating scale subscore B | -0.2 units on a scale | Standard Deviation 0.5 |
| Rotatory Torticollis | 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) | Change to Week 12 in Tsui rating scale subscore C | -0.2 units on a scale | Standard Deviation 0.8 |
| Rotatory Torticollis | 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) | Change to Week 12 in Tsui rating scale subscore D | -0.4 units on a scale | Standard Deviation 0.9 |
| Laterocollis | 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) | Chang to Week 4 in Tsui rating scale subscore C | -0.6 units on a scale | Standard Deviation 0.8 |
| Laterocollis | 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) | Change to Week 12 in Tsui rating scale subscore C | -0.3 units on a scale | Standard Deviation 0.7 |
| Laterocollis | 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) | Change to Week 4 in Tsui rating scale subscore D | -0.5 units on a scale | Standard Deviation 1 |
| Laterocollis | 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) | Change to Week 12 in Tsui rating scale subscore A | -0.9 units on a scale | Standard Deviation 1.2 |
| Laterocollis | 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) | Change to Week 12 in Tsui rating scale subscore B | -0.1 units on a scale | Standard Deviation 0.4 |
| Laterocollis | 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) | Change to Week 4 in Tsui rating scale subscore A | -1.5 units on a scale | Standard Deviation 1.2 |
| Laterocollis | 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) | Change to Week 4 in Tsui rating scale subscore B | -0.3 units on a scale | Standard Deviation 0.5 |
| Laterocollis | 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) | Change to Week 12 in Tsui rating scale subscore D | -0.3 units on a scale | Standard Deviation 0.9 |
| Dysport® 500 U - Total Study Population | 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) | Chang to Week 4 in Tsui rating scale subscore C | -0.4 units on a scale | Standard Deviation 0.8 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 4 in Tsui rating scale subscore B | -0.3 units on a scale | Standard Deviation 0.6 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 4 in Tsui rating scale subscore A | -1.4 units on a scale | Standard Deviation 1.3 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 4 in Tsui rating scale subscore D | -0.6 units on a scale | Standard Deviation 1 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 12 in Tsui rating scale subscore C | -0.2 units on a scale | Standard Deviation 0.8 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 12 in Tsui rating scale subscore B | -0.2 units on a scale | Standard Deviation 0.5 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 12 in Tsui rating scale subscore A | -0.8 units on a scale | Standard Deviation 1.3 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 12 in Tsui rating scale subscore D | -0.4 units on a scale | Standard Deviation 0.9 |
Secondary
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)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotatory Torticollis | 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) | Change to Week 4 in CDQ-24 total score | -11.1 units on a scale | Standard Deviation 16.1 |
| Rotatory Torticollis | 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) | Change to Week 4 in CDQ-24 Stigma subscale | -16.8 units on a scale | Standard Deviation 24 |
| Rotatory Torticollis | 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) | Change to Week 4 in CDQ-24 Emotional subscale | -10.3 units on a scale | Standard Deviation 19.9 |
| Rotatory Torticollis | 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) | Change to Week 4 in CDQ-24 Pain subscale | -11.5 units on a scale | Standard Deviation 27.8 |
| Rotatory Torticollis | 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) | Change to Week 4 in CDQ-24 ADL subscale | -11.1 units on a scale | Standard Deviation 19.6 |
| Rotatory Torticollis | 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) | Change to Week 4 in CDQ-24 Social subscale | -5.6 units on a scale | Standard Deviation 17.9 |
| Rotatory Torticollis | 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) | Change to Week 12 in CDQ-24 total score | -11.8 units on a scale | Standard Deviation 14.6 |
| Rotatory Torticollis | 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) | Change to Week 12 in CDQ-24 Stigma subscale | -16.4 units on a scale | Standard Deviation 22.5 |
| Rotatory Torticollis | 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) | Change to Week 12 in CDQ-24 Emotional subscale | -11.1 units on a scale | Standard Deviation 18.7 |
| Rotatory Torticollis | 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) | Change to Week 12 in CDQ-24 Pain subscale | -13.2 units on a scale | Standard Deviation 25.5 |
| Rotatory Torticollis | 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) | Change to Week 12 in CDQ-24 ADL subscale | -12.5 units on a scale | Standard Deviation 18.6 |
| Rotatory Torticollis | 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) | Change to Week 12 in CDQ-24 Social life subscale | -6.7 units on a scale | Standard Deviation 17.8 |
Secondary
Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotatory Torticollis | Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12) | -2.3 units on a scale | Standard Deviation 3.4 |
| Laterocollis | Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12) | -2.4 units on a scale | Standard Deviation 2.5 |
| Dysport® 500 U - Total Study Population | Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12) | -2.3 units on a scale | Standard Deviation 3.2 |
Secondary
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)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotatory Torticollis | 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) | Change to Week 4 in total Tsui score | -3.8 units on a scale | Standard Deviation 3.2 |
| Rotatory Torticollis | 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) | Change to Week 12 in total Tsui score | -2.3 units on a scale | Standard Deviation 3.6 |
| Laterocollis | 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) | Change to Week 4 in total Tsui score | -4.3 units on a scale | Standard Deviation 2.9 |
| Laterocollis | 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) | Change to Week 12 in total Tsui score | -2.3 units on a scale | Standard Deviation 3.1 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 4 in total Tsui score | -3.9 units on a scale | Standard Deviation 3.2 |
| Dysport® 500 U - Total Study Population | 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) | Change to Week 12 in total Tsui score | -2.3 units on a scale | Standard Deviation 3.5 |
Secondary
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)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotatory Torticollis | 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) | Change to Week 4 in Day-to-day functions | -1.1 units on a scale | Standard Deviation 3 |
| Rotatory Torticollis | 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) | Change to Week 4 in Pain | -0.8 units on a scale | Standard Deviation 2.7 |
| Rotatory Torticollis | 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) | Change to Week 4 in Duration of pain | -1.2 units on a scale | Standard Deviation 2.9 |
| Rotatory Torticollis | 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) | Change to Week 12 in Day-to-day functions | -1.1 units on a scale | Standard Deviation 2.6 |
| Rotatory Torticollis | 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) | Change to Week 12 in Pain | -0.9 units on a scale | Standard Deviation 2.5 |
| Rotatory Torticollis | 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) | Change to Week 12 in Duration of pain | -1.3 units on a scale | Standard Deviation 2.7 |
Secondary
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 (Investigator assessment): Very good | 129 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 (Investigator assessment): Good | 221 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 (Investigator assessment): Moderate | 109 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 (Investigator assessment): Insufficient | 41 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 12 (Investigator assessment): Very good | 134 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 12 (Investigator assessment): Good | 218 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 12 (Investigator assessment): Moderate | 102 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 12 (Investigator assessment): Insufficient | 35 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 (Patient assessment): Very good | 97 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 (Patient assessment): Good | 207 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 (Patient assessment): Moderate | 113 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 4 (Patient assessment): Insufficient | 83 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 12 (Patient assessment): Very good | 113 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 12 (Patient assessment): Good | 205 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 12 (Patient assessment): Moderate | 100 Participants |
| Rotatory Torticollis | Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) | Week 12 (Patient assessment): Insufficient | 72 Participants |
Secondary
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)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotatory Torticollis | 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) | No pain at Week 4 (Investigator assessment) | 131 Participants |
| Rotatory Torticollis | 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) | Less pain at Week 4 (Investigator assessment) | 205 Participants |
| Rotatory Torticollis | 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) | No change at Week 4 (Investigator assessment) | 94 Participants |
| Rotatory Torticollis | 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) | More pain at Week 4 (Investigator assessment) | 70 Participants |
| Rotatory Torticollis | 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) | No pain at Week 12 (Investigator assessment) | 142 Participants |
| Rotatory Torticollis | 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) | Less pain at Week 12 (Investigator assessment) | 227 Participants |
| Rotatory Torticollis | 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) | No change at Week 12 (Investigator assessment) | 87 Participants |
| Rotatory Torticollis | 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) | More pain at Week 12 (Investigator assessment) | 33 Participants |
| Rotatory Torticollis | 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) | No pain at Week 4 (Patient assessment) | 128 Participants |
| Rotatory Torticollis | 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) | Less pain at Week 4 (Patient assessment) | 202 Participants |
| Rotatory Torticollis | 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) | No change at Week 4 (Patient assessment) | 82 Participants |
| Rotatory Torticollis | 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) | More pain at Week 4 (Patient assessment) | 88 Participants |
| Rotatory Torticollis | 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) | No pain at Week 12 (Patient assessment) | 132 Participants |
| Rotatory Torticollis | 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) | Less pain at Week 12 (Patient assessment) | 231 Participants |
| Rotatory Torticollis | 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) | No change at Week 12 (Patient assessment) | 83 Participants |
| Rotatory Torticollis | 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) | More pain at Week 12 (Patient assessment) | 44 Participants |