Phase IV-Cervical Dystonia-INTEREST IN CD2

Study Overview
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Brief Summary
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The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

Official Title
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An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact

Conditions
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Cervical Dystonia

Intervention / Treatment
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* Biological: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject for whom there is an intention to treat with BoNT-A. BoNT treatment naïve or previously treated with BoNT. If previously treated with BoNT, at least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion. Subject able to comply with the protocol. Provision of written informed consent prior to collect the data. Exclusion Criteria: Contraindications to any BoNT-A preparations. The subject has already been included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic cervical dystonia<br>Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia. BoNT-A injections, 3-4 times yearly. | Biological: Botulinum toxin type A<br>* Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subject's satisfaction using a 5-point Likert scale. | Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD. | Baseline and at every 3 to 4 months, up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale. | Assessment of severity of CD. | Baseline and at every 3 to 4 months, up to 3 years. | 
| Change in tremor associated with CD using Tsui score |  | Baseline and at every 3 to 4 months, up to 3 years. | 
| Change in pain relief assessed using the TWSTRS pain sub-scale. |  | Baseline and at every 3 to 4 months, up to 3 years. | 
| Change in disability will be measured with the TWSTRS disability sub-scale. |  | Baseline and at every 3 to 4 months, up to 3 years. | 
| Pharmaco-economic endpoints | Time intervals between injections Changes in concomitant treatments for CD and associated symptoms. Changes in employment status | Baseline and at every 3 to 4 months, up to 3 years. |