Cervical Dystonia
Conditions
Brief summary
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.
Interventions
BIOLOGICALBotulinum toxin type A
500 units
DRUGPlacebo
500 units
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status * TWSTRS severity, disability and total scores meeting the defined criteria at baseline
Exclusion criteria
* Pure anterocollis or pure retrocollis * In apparent remission from cervical dystonia * Previous poor response to the last two botulinum toxin type A or type B treatments * Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline and Week 4 | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Baseline and Week 12 | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline. |
| Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment | Baseline and Week 4 | The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms). |
| Investigator VAS for CD Symptom Assessment | Baseline and Week 4 | The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms). |
| Subject VAS for CD Symptom Assessment | Baseline and Week 8 | The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms). |
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline and Week 8 | TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline. |
| SF-36 Mental Health Summary Score | Week 8 | SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health). |
| SF-36 Physical Health Summary Score | Week 8 | SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health). |
| Number of Participants Considered by the Investigator to be Overall Treatment Successes | Week 12 | The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed. |
| Investigator's VAS for CD Symptom Assessment | Baseline and week 8 | The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms). |
Countries
Russia, United States
Participant flow
Recruitment details
Patients were recruited at 16 centres in the USA and 4 centres in Russia from October 2005 until September 2006
Participants by arm
| Arm | Count |
|---|---|
| Dysport 500 Units Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | 55 |
| Placebo Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | 61 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 5 | 23 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | No longer wanted to do blood draws | 1 | 0 |
| Overall Study | PI & Subject Schedule Conflicts | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Dysport 500 Units | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 9 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 46 Participants | 50 Participants |
| Age, Continuous | 53.0 years STANDARD_DEVIATION 12.9 | 51.9 years STANDARD_DEVIATION 13.4 | 53.9 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment Russian Federation | 28 participants | 14 participants | 14 participants |
| Region of Enrollment United States | 88 participants | 41 participants | 47 participants |
| Sex: Female, Male Female | 75 Participants | 37 Participants | 38 Participants |
| Sex: Female, Male Male | 41 Participants | 18 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 55 | 5 / 61 |
| serious Total, serious adverse events | 0 / 55 | 1 / 61 |
Outcome results
Primary
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time frame: Baseline and Week 4
Population: The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Change in TWSTRS total score | -13.99 points on a scale | Standard Deviation 12.33 |
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline TWSTRS total score | 43.83 points on a scale | Standard Deviation 7.97 |
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Week 4 TWSTRS total score | 30.04 points on a scale | Standard Deviation 12.65 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Change in TWSTRS total score | -5.23 points on a scale | Standard Deviation 9.33 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline TWSTRS total score | 45.81 points on a scale | Standard Deviation 8.78 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Week 4 TWSTRS total score | 40.22 points on a scale | Standard Deviation 11.75 |
p-value: <0.000195% CI: [-12.94, -4.74]ANCOVA
Secondary
Investigator's VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time frame: Baseline and week 8
Population: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline and Week 4 values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Investigator's VAS for CD Symptom Assessment | Change in Investigator VAS for CD symptoms | -20.5 points on a scale | Standard Deviation 22.7 |
| Dysport 500 Units | Investigator's VAS for CD Symptom Assessment | Baseline Investigator VAS for CD symptoms | 62.3 points on a scale | Standard Deviation 15.8 |
| Dysport 500 Units | Investigator's VAS for CD Symptom Assessment | Week 8 Investigator VAS for CD symptoms | 40.8 points on a scale | Standard Deviation 22.3 |
| Placebo | Investigator's VAS for CD Symptom Assessment | Change in Investigator VAS for CD symptoms | -5.0 points on a scale | Standard Deviation 21.3 |
| Placebo | Investigator's VAS for CD Symptom Assessment | Baseline Investigator VAS for CD symptoms | 65.3 points on a scale | Standard Deviation 18 |
| Placebo | Investigator's VAS for CD Symptom Assessment | Week 8 Investigator VAS for CD symptoms | 60.8 points on a scale | Standard Deviation 24.6 |
p-value: <0.00195% CI: [-24.2, -7.8]ANCOVA
Secondary
Investigator's VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
Time frame: Baseline and week 12
Population: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline, Week 4 and Week 8 values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Investigator's VAS for CD Symptom Assessment | Change in Investigator VAS for CD symptoms | -8.5 points on a scale | Standard Deviation 18.9 |
| Dysport 500 Units | Investigator's VAS for CD Symptom Assessment | Baseline Investigator VAS for CD symptoms | 62.3 points on a scale | Standard Deviation 15.8 |
| Dysport 500 Units | Investigator's VAS for CD Symptom Assessment | Week 12 Investigator VAS for CD symptoms | 54.8 points on a scale | Standard Deviation 20.8 |
| Placebo | Investigator's VAS for CD Symptom Assessment | Change in Investigator VAS for CD symptoms | -5.8 points on a scale | Standard Deviation 15.8 |
| Placebo | Investigator's VAS for CD Symptom Assessment | Baseline Investigator VAS for CD symptoms | 65.3 points on a scale | Standard Deviation 18 |
| Placebo | Investigator's VAS for CD Symptom Assessment | Week 12 Investigator VAS for CD symptoms | 60.0 points on a scale | Standard Deviation 21.5 |
p-value: 0.02895% CI: [-13.3, -0.8]ANCOVA
Secondary
Investigator VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time frame: Baseline and Week 4
Population: Analysis was performed on intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Investigator VAS for CD Symptom Assessment | Change in Investigator VAS for CD symptoms | -23.1 points on a scale | Standard Deviation 22.1 |
| Dysport 500 Units | Investigator VAS for CD Symptom Assessment | Baseline Investigator VAS for CD symptoms | 62.3 points on a scale | Standard Deviation 15.8 |
| Dysport 500 Units | Investigator VAS for CD Symptom Assessment | Week 4 Investigator VAS for CD symptoms | 40.3 points on a scale | Standard Deviation 21.7 |
| Placebo | Investigator VAS for CD Symptom Assessment | Change in Investigator VAS for CD symptoms | -9.1 points on a scale | Standard Deviation 20.2 |
| Placebo | Investigator VAS for CD Symptom Assessment | Baseline Investigator VAS for CD symptoms | 65.3 points on a scale | Standard Deviation 18 |
| Placebo | Investigator VAS for CD Symptom Assessment | Week 4 Investigator VAS for CD symptoms | 56.8 points on a scale | Standard Deviation 21.8 |
p-value: <0.00195% CI: [-22.3, -6.1]ANCOVA
Secondary
Number of Participants Considered by the Investigator to be Overall Treatment Successes
The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Time frame: Week 12
Population: Analysis was performed on intention to treat population which consisted of 55 participants on Dysport and 61 on Placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dysport 500 Units | Number of Participants Considered by the Investigator to be Overall Treatment Successes | 32 participants |
| Placebo | Number of Participants Considered by the Investigator to be Overall Treatment Successes | 10 participants |
Comparison: The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.p-value: <0.000195% CI: [3.01, 17.26]odds ratio
Secondary
SF-36 Mental Health Summary Score
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).
Time frame: Week 8
Population: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in mental health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | SF-36 Mental Health Summary Score | Change in SF-36 Mental health summary Score | 4.11 points on a scale | Standard Deviation 9.18 |
| Dysport 500 Units | SF-36 Mental Health Summary Score | Baseline SF-36 Mental health summary Score | 44.52 points on a scale | Standard Deviation 10.41 |
| Dysport 500 Units | SF-36 Mental Health Summary Score | Week 8 SF-36 Mental health summary Score | 49.00 points on a scale | Standard Deviation 8.69 |
| Placebo | SF-36 Mental Health Summary Score | Change in SF-36 Mental health summary Score | 2.48 points on a scale | Standard Deviation 8.12 |
| Placebo | SF-36 Mental Health Summary Score | Baseline SF-36 Mental health summary Score | 43.31 points on a scale | Standard Deviation 11.14 |
| Placebo | SF-36 Mental Health Summary Score | Week 8 SF-36 Mental health summary Score | 43.41 points on a scale | Standard Deviation 12.3 |
p-value: 0.06195% CI: [-0.17, 7.47]ANCOVA
Secondary
SF-36 Physical Health Summary Score
SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).
Time frame: Week 8
Population: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in physical health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | SF-36 Physical Health Summary Score | Change in SF-36 Physical health summary score | 4.37 points on a scale | Standard Deviation 5.46 |
| Dysport 500 Units | SF-36 Physical Health Summary Score | Baseline SF-36 Physical health summary score | 39.42 points on a scale | Standard Deviation 8.84 |
| Dysport 500 Units | SF-36 Physical Health Summary Score | Week 8 SF-36 Physical health summary score | 43.70 points on a scale | Standard Deviation 8.76 |
| Placebo | SF-36 Physical Health Summary Score | Change in SF-36 Physical health summary score | -0.64 points on a scale | Standard Deviation 6.41 |
| Placebo | SF-36 Physical Health Summary Score | Baseline SF-36 Physical health summary score | 43.18 points on a scale | Standard Deviation 7.89 |
| Placebo | SF-36 Physical Health Summary Score | Week 8 SF-36 Physical health summary score | 42.49 points on a scale | Standard Deviation 8.84 |
p-value: 0.00295% CI: [1.73, 7.58]ANCOVA
Secondary
Subject VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
Time frame: Baseline and Week 8
Population: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline and Week 4 values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Subject VAS for CD Symptom Assessment | Change in subject VAS for CD symptoms | -24.6 points on a scale | Standard Deviation 30 |
| Dysport 500 Units | Subject VAS for CD Symptom Assessment | Baseline subject VAS for CD symptoms | 67.7 points on a scale | Standard Deviation 19.7 |
| Dysport 500 Units | Subject VAS for CD Symptom Assessment | Week 8 subject VAS for CD symptoms | 44.7 points on a scale | Standard Deviation 24.9 |
| Placebo | Subject VAS for CD Symptom Assessment | Change in subject VAS for CD symptoms | -5.4 points on a scale | Standard Deviation 25.4 |
| Placebo | Subject VAS for CD Symptom Assessment | Baseline subject VAS for CD symptoms | 63.6 points on a scale | Standard Deviation 18.9 |
| Placebo | Subject VAS for CD Symptom Assessment | Week 8 subject VAS for CD symptoms | 57.8 points on a scale | Standard Deviation 27.5 |
p-value: <0.00195% CI: [-25.8, -8.1]ANCOVA
Secondary
Subject VAS for CD Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time frame: Baseline and week 12
Population: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline, Week 4 and Week 8 values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Subject VAS for CD Symptom Assessment | Change in subject VAS for CD symptoms | -14.4 points on a scale | Standard Deviation 25.2 |
| Dysport 500 Units | Subject VAS for CD Symptom Assessment | Baseline subject VAS for CD symptoms | 67.7 points on a scale | Standard Deviation 19.7 |
| Dysport 500 Units | Subject VAS for CD Symptom Assessment | Week 12 subject VAS for CD symptoms | 55.4 points on a scale | Standard Deviation 25.5 |
| Placebo | Subject VAS for CD Symptom Assessment | Change in subject VAS for CD symptoms | -4.6 points on a scale | Standard Deviation 23.3 |
| Placebo | Subject VAS for CD Symptom Assessment | Baseline subject VAS for CD symptoms | 63.6 points on a scale | Standard Deviation 18.9 |
| Placebo | Subject VAS for CD Symptom Assessment | Week 12 subject VAS for CD symptoms | 58.2 points on a scale | Standard Deviation 25.7 |
p-value: 0.00795% CI: [-19, -3.1]ANCOVA
Secondary
Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment
The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
Time frame: Baseline and Week 4
Population: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 5 subjects on Dysport and 8 on placebo who were not assessed on the change in subject VAS score for CD symptoms at Week 4. There was no imputation of missing VAS scores, so these 13 subjects were not taken into account.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment | Change in Subject VAS for CD symptoms | -24.2 points on a scale | Standard Deviation 29.5 |
| Dysport 500 Units | Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment | Baseline Subject VAS for CD symptoms | 67.7 points on a scale | Standard Deviation 19.7 |
| Dysport 500 Units | Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment | Week 4 Subject VAS for CD symptoms | 44.3 points on a scale | Standard Deviation 24.4 |
| Placebo | Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment | Change in Subject VAS for CD symptoms | -6.7 points on a scale | Standard Deviation 20.8 |
| Placebo | Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment | Baseline Subject VAS for CD symptoms | 63.6 points on a scale | Standard Deviation 18.9 |
| Placebo | Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment | Week 4 Subject VAS for CD symptoms | 55.7 points on a scale | Standard Deviation 20.6 |
p-value: <0.00195% CI: [-24, -6.4]ANCOVA
Secondary
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time frame: Baseline and Week 8
Population: The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 9 subjects for Dysport and 15 for placebo who were not assessed on TWSTRS score at Week 8. As there was no imputation of missing TWSTRS score values, these 24 subjects were not taken into account.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Change in TWSTRS total score | -13.82 points on a scale | Standard Deviation 11.53 |
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline TWSTRS total score | 43.83 points on a scale | Standard Deviation 7.97 |
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Week 8 TWSTRS total score | 29.31 points on a scale | Standard Deviation 10.99 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Change in TWSTRS total score | -5.59 points on a scale | Standard Deviation 11.37 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Baseline TWSTRS total score | 45.81 points on a scale | Standard Deviation 8.78 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Week 8 TWSTRS total score | 39.64 points on a scale | Standard Deviation 13.5 |
p-value: <0.000195% CI: [-12.91, -4.71]ANCOVA
Secondary
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.
Time frame: Baseline and Week 12
Population: The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 10 subjects for Dysport and 17 for placebo who were not assessed on TWSTRS score at Week 12. As there was no imputation of missing TWSTRS score values, these 27 subjects were not taken into account.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Change in TWSTRS total score | -6.98 points on a scale | Standard Deviation 11.12 |
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Baseline TWSTRS total score | 43.83 points on a scale | Standard Deviation 7.97 |
| Dysport 500 Units | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Week 12 TWSTRS total score | 36.04 points on a scale | Standard Deviation 11.76 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Change in TWSTRS total score | -4.53 points on a scale | Standard Deviation 7.75 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Baseline TWSTRS total score | 45.81 points on a scale | Standard Deviation 8.78 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score | Week 12 TWSTRS total score | 40.76 points on a scale | Standard Deviation 11.08 |
p-value: 0.01995% CI: [-7.55, -0.68]ANCOVA