Status:
COMPLETED
Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
Lead Sponsor:
Ipsen
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with...
Eligibility Criteria
Inclusion
- De novo patients with cervical dystonia
- Outpatient
- Patients to be of age 18 years or older
- Written informed consent to participate in the study
Exclusion
- Pre-treatment of cervical dystonia with botulinum toxin
- Pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months
- Pure retro- or antecollis
- Neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, Bekhterev's disease
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT00447772
Start Date
October 1 2004
End Date
April 1 2008
Last Update
March 30 2023
Active Locations (106)
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1
Krankenhaus der Barmherzigen Brüder
Graz, Austria, A-8020
2
NÖ LKH Grimmenstein-Hochegg
Grimmenstein, Austria, A-2240
3
Univ.-Klinik für Neurologie
Innsbruck, Austria, A-6020
4
Konventhospital der Barmherzigen Brüder
Linz, Austria, A-4014