| 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. | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| | | Title | Denominators | Categories |
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| Change in TWSTRS total score | | | Title | Measurements |
|---|
| - OG000-13.99± 12.33
- OG001-5.23± 9.33
|
| | Baseline TWSTRS total score | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model. | <0.0001 | A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant. | Mean Difference (Net) | -8.84 | | | 2-Sided | 95 | -12.94 | -4.74 | | | Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed. Mean difference = difference in adjusted least squares mean (Dysport - Placebo). |
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| 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. | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | points on a scale | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
| |
| 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. | Analysis was performed on intention to treat population which consisted of 55 participants on Dysport and 61 on Placebo. | Posted | | Number | | participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Dysport 500 Units | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible | | OG001 | Placebo | Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible |
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