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.
Conditions
Interventions
Trade Name: Dysport®
Product Name: Botulinum toxin type A
Pharmaceutical Form: Powder for injection*
Sponsors
Ipsen Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The results of a dose finding study have shown that 500 units Dysport® are the optimal starting dose for the treatment of patients with rotational torticollis. Although Dysport is an established first-line neurological treatment for cervical dystonia since its registration in Germany in 1995, there are only little data available on dose, efficacy and safety in the treatment of heterogeneous forms of cervical dystonia. The aim of this multicentre open study is to demonstrate the equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport. ;Secondary Objective: Quality of life in week 0, 4 and 12 (disease specific craniocervical dystonia questionnaire, CDQ-24, Müller et al., 2004), efficacy assessment by patient and investigator, safety / tolerance / pain assessment by patient and investigator, patient diary (weekly documentation of function in every day life activities, pain and pain duration), documentation of dose and injection protocol of the following treatment after end of the study, documentation of adverse events / adverse drug reactions, descriptive analyses of cervical dystonia subgroups, Tsui-Score over week 0, 4 and 12 (while patient sitting), optional: additional Tsui-Score rating while patient walking, comparison Tsui-Score patient sitting and patient walking;Primary end point(s): Tsui-Score in weeks 4 vs. baseline in week 0 (rating while patient sitting). | — |
Countries
Austria
Outcome results
None listed