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The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects naïve to botulinum toxin A (BoNT-A) treatment | Patients naïve to botulinum toxin A treatment | ||
| Subjects pre-treated with botulinum toxin A (BoNT-A) injection | Patients pre-treated with botulinum toxin A for at least 2 years. 4 injection cycles, each at 3 to 4 months intervals. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Tsui scores | The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner. | Baseline and 12 weeks post-injection Cycle 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tsui scores | The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner. | Baseline and 12 weeks post-injection Cycle 1 |
| Change in Tsui scores |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from cervical dystonia
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz | Austria | |||||
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.
| Baseline and 12 weeks post-injection Cycle 3 |
| Change in Tsui scores | The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner. | Baseline and 12 weeks post-injection Cycle 4 |
| Wiesbaden |
| Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |