Open, multicentre study on the equivalent efficacy and safety of Botulinum toxin A (500 Units Dysport®) in the treatment of heterogeneous forms of cervical dystonia - Dysport CD-Study
- Conditions
- Cervical dystonia (CD), one of the most common forms of focal dystonia, is characterised by an altered head posture, pain in the the neck and shoulder region and hypertrophy of the concerned muscles. Over the past 15 years local injections of botulinum toxin into various neck muscles have become the first line therapeutic approach.
- Registration Number
- EUCTR2004-002086-20-AT
- Lead Sponsor
- Ipsen Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1.De novo patients with cervical dystonia, but not pure retro-or antecollis
2.Ambulant patients
3.Age 18 and older
4.Written consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Pre-treatment of cervical dystonia with botulinum toxin
2.Pre-treatment with botulinum toxin in any other indication than cervical dystonia within the past 12 months
3.Known allergy or antibodies against botulinum toxin
4.Pure retro- or antecollis
5.Pure tremor capitis
6.Pure shift (sagittal or lateral)
7.Dysphagia
8.Serious respiratory tract diseases in need of treatment
9.Ingestion of neuroleptics or hidden neuroleptics, e.g. Paspertin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method