Cervical Dystonia
Conditions
Brief summary
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).
Interventions
BIOLOGICALBotulinum toxin type A
Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in subject's satisfaction using a 5-point Likert scale. | Baseline and at every 3 to 4 months, up to 3 years. | Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale. | Baseline and at every 3 to 4 months, up to 3 years. | Assessment of severity of CD. |
| 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 | Baseline and at every 3 to 4 months, up to 3 years. | * Time intervals between injections * Changes in concomitant treatments for CD and associated symptoms. * Changes in employment status |
Countries
Algeria, Australia, Austria, Belgium, Brazil, China, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Jordan, Latvia, Lebanon, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, South Korea, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, United Kingdom, United States
Outcome results
None listed