Cervical Dystonia
Conditions
Brief summary
At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.
Interventions
DRUGincobotulinumtoxinA (Xeomin) (240 Units)
incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (240 Units)
DRUGincobotulinumtoxinA (Xeomin) (120 Units)
incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (120 Units)
DRUGPlacebo
Placebo
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male or female outpatients between ages 18 and 75 years inclusive) * A clinical diagnosis of cervical dystonia (i.e. spasmodic torticollis) with predominantly rotational form and a need for injection (determined by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score) * TWSTRS-Total score \>= 20 * TWSTRS-Severity score \>= 10 * TWSTRS-Disability score \>= 3 * TWSTRS-Pain score \>= 1 * On a stable dose of medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period * For pre-treated patients only: Source documentation of the last two consecutive injection sessions with Botulinum Toxin and stable therapeutic response directly prior to trial entry * For pre-treated patients only: At least 10 weeks must have been passed between the last injection with Botulinum Toxin for cervical dystonia and baseline * For pre-treated patients only: The most recent injection with Botulinum Toxin must have been maximal 300 Units of type A or 12,000 Units of type B Main
Exclusion criteria
* Traumatic torticollis or tardive torticollis * TWSTRS-Severity score for anterocollis \>= 2 points (pure anterocollis) * TWSTRS-Severity score for retrocollis \>= 2 points (pure retrocollis) * Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation) * Hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin Type A * Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial * Current swallowing disorder of any origin (dysphagia scale \>= 3, i.e. severe, with swallowing difficulties and requiring a change in diet) * Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spine syndrome * Treatment with Botulinum Toxins for any indication other than cervical dystonia within 4 months prior to baseline and during the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | Baseline, week 4 | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo | Baseline, week 4 | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units) | Baseline, week 4 | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the TWSTRS Pain Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Change From Baseline in the TWSTRS-Total Score | Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period) | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Patient Evaluation of Global Response (PEGR) at Final Visit | Final visit (up to 20 weeks after injection of the Main Period) | The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4). |
| Change From Baseline in the TWSTRS Disability Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Change From Baseline in the TWSTRS Severity Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection | 81 |
| incobotulinumtoxinA (Xeomin) (120 Units) incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection | 78 |
| Placebo Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection | 74 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Extension Period - up to 68 Weeks | Adverse Event | 1 | 0 | 0 |
| Extension Period - up to 68 Weeks | Consent Withdrawn | 4 | 4 | 0 |
| Extension Period - up to 68 Weeks | Lack of Efficacy | 11 | 11 | 0 |
| Extension Period - up to 68 Weeks | Lost to Follow-up | 5 | 5 | 0 |
| Extension Period - up to 68 Weeks | Patient Decision | 1 | 2 | 0 |
| Extension Period - up to 68 Weeks | Physician Decision | 1 | 2 | 0 |
| Extension Period - up to 68 Weeks | Withdrawal Criteria Occurred | 4 | 5 | 0 |
| Main Period - 8 to 20 Weeks | Adverse Event | 2 | 1 | 0 |
| Main Period - 8 to 20 Weeks | Consent Withdrawn | 1 | 1 | 1 |
| Main Period - 8 to 20 Weeks | Lack of Efficacy | 0 | 0 | 3 |
| Main Period - 8 to 20 Weeks | Lost to Follow-up | 1 | 1 | 1 |
| Main Period - 8 to 20 Weeks | Patient Decision | 1 | 0 | 0 |
| Main Period - 8 to 20 Weeks | Withdrawal Criteria Occurred | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | incobotulinumtoxinA (Xeomin) (240 Units) | incobotulinumtoxinA (Xeomin) (120 Units) | Placebo | Total |
|---|---|---|---|---|
| Age Continuous | 53.2 years STANDARD_DEVIATION 12.2 | 52.8 years STANDARD_DEVIATION 11.5 | 52.4 years STANDARD_DEVIATION 10.8 | 52.8 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 54 Participants | 51 Participants | 49 Participants | 154 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 25 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 81 | 26 / 78 | 14 / 74 |
| serious Total, serious adverse events | 4 / 81 | 0 / 78 | 0 / 74 |
Outcome results
Primary
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 4
Population: Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo | -10.8 points on a scale | Standard Error 2.11 |
| Placebo | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo | -3.3 points on a scale | Standard Error 2.2 |
Comparison: Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.p-value: <0.00195% CI: [-10.4, -4.6]ANCOVA
Primary
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 4
Population: Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | -7.3 points on a scale | Standard Error 2.18 |
| Placebo | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | 1.6 points on a scale | Standard Error 2.28 |
Comparison: Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.p-value: <0.00195% CI: [-12, -5.9]ANCOVA
Primary
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 4
Population: Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units) | -10.5 points on a scale | Standard Error 2.25 |
| Placebo | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units) | -9.2 points on a scale | Standard Error 2.27 |
Comparison: Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.p-value: 0.44795% CI: [-2.1, 4.6]ANCOVA
Secondary
Change From Baseline in the TWSTRS Disability Subscore
TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Population: Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Week 8 | -2.4 points on a scale | Standard Deviation 3.98 |
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Week 4 | -3.0 points on a scale | Standard Deviation 4.35 |
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Final Visit | -1.3 points on a scale | Standard Deviation 3.13 |
| Placebo | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Week 8 | -2.1 points on a scale | Standard Deviation 4.86 |
| Placebo | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Week 4 | -3.3 points on a scale | Standard Deviation 4.72 |
| Placebo | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Final Visit | -1.4 points on a scale | Standard Deviation 3.82 |
| Placebo | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Week 4 | 0.0 points on a scale | Standard Deviation 3.41 |
| Placebo | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Final Visit | 1.0 points on a scale | Standard Deviation 3.32 |
| Placebo | Change From Baseline in the TWSTRS Disability Subscore | Baseline - Week 8 | 0.8 points on a scale | Standard Deviation 3.27 |
Secondary
Change From Baseline in the TWSTRS Pain Subscore
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Population: Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Week 8 | -2.3 points on a scale | Standard Deviation 4.32 |
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Week 4 | -2.4 points on a scale | Standard Deviation 4.36 |
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Final Visit | -1.3 points on a scale | Standard Deviation 3.4 |
| Placebo | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Week 8 | -1.8 points on a scale | Standard Deviation 4.15 |
| Placebo | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Week 4 | -2.7 points on a scale | Standard Deviation 4.55 |
| Placebo | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Final Visit | -1.1 points on a scale | Standard Deviation 3.96 |
| Placebo | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Week 4 | -0.3 points on a scale | Standard Deviation 2.97 |
| Placebo | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Final Visit | 0.9 points on a scale | Standard Deviation 2.56 |
| Placebo | Change From Baseline in the TWSTRS Pain Subscore | Baseline - Week 8 | 0.6 points on a scale | Standard Deviation 2.82 |
Secondary
Change From Baseline in the TWSTRS Severity Subscore
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)
Population: Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Week 8 | -3.5 points on a scale | Standard Deviation 5.39 |
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Final Visit | -1.9 points on a scale | Standard Deviation 3.83 |
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Week 4 | -5.5 points on a scale | Standard Deviation 5.99 |
| Placebo | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Week 4 | -3.9 points on a scale | Standard Deviation 4.34 |
| Placebo | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Week 8 | -3.1 points on a scale | Standard Deviation 4.39 |
| Placebo | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Final Visit | -1.1 points on a scale | Standard Deviation 3.18 |
| Placebo | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Week 8 | -0.9 points on a scale | Standard Deviation 3.57 |
| Placebo | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Week 4 | -1.9 points on a scale | Standard Deviation 3.96 |
| Placebo | Change From Baseline in the TWSTRS Severity Subscore | Baseline - Final Visit | -0.2 points on a scale | Standard Deviation 3.07 |
Secondary
Change From Baseline in the TWSTRS-Total Score
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time frame: Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)
Population: Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS-Total Score | Baseline - Week 8 | -8.2 points on a scale | Standard Deviation 10.54 |
| incobotulinumtoxinA (Xeomin) (240 Units) | Change From Baseline in the TWSTRS-Total Score | Baseline - Final Visit | -4.6 points on a scale | Standard Deviation 7.52 |
| Placebo | Change From Baseline in the TWSTRS-Total Score | Baseline - Week 8 | -6.9 points on a scale | Standard Deviation 11.15 |
| Placebo | Change From Baseline in the TWSTRS-Total Score | Baseline - Final Visit | -3.6 points on a scale | Standard Deviation 8.07 |
| Placebo | Change From Baseline in the TWSTRS-Total Score | Baseline - Week 8 | 0.4 points on a scale | Standard Deviation 7.17 |
| Placebo | Change From Baseline in the TWSTRS-Total Score | Baseline - Final Visit | 1.7 points on a scale | Standard Deviation 6.15 |
Secondary
Patient Evaluation of Global Response (PEGR) at Final Visit
The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4).
Time frame: Final visit (up to 20 weeks after injection of the Main Period)
Population: Intention to treat population with missing values imputed by no effect
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) (240 Units) | Patient Evaluation of Global Response (PEGR) at Final Visit | 1.3 points on a scale | Standard Deviation 1.84 |
| Placebo | Patient Evaluation of Global Response (PEGR) at Final Visit | 1.3 points on a scale | Standard Deviation 1.77 |
| Placebo | Patient Evaluation of Global Response (PEGR) at Final Visit | -0.2 points on a scale | Standard Deviation 1.34 |