Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
- Conditions
- Idiopathic Cervical Dystonia
- Registration Number
- NCT00833196
- Lead Sponsor
- Ipsen
- Brief Summary
A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
- Idiopathic cervical dystonia
- TWSTRS severity score ≥ 15
- At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion
- Written informed consent prior to collect the data
- Contraindications to any BoNT-A preparations
- Secondary cervical dystonia
- Subject already been included in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice Around 4 weeks post injection
- Secondary Outcome Measures
Name Time Method To describe subject and investigator's CGI scores Around 4 weeks post injection To describe TWSTRS change scores from inclusion (total score & subscales scores) Baseline, and around 4 weeks and 3 months post injection To describe tremor change score from inclusion (TSUI scale) Baseline, and around 4 weeks and 3 months post injection To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion Baseline, and around 4 weeks post injection To identify prognostic factors for response (Exploratory Objective) baseline, and around 4 weeks and 3 months post injection
Trial Locations
- Locations (36)
Royal Prince Alfred Hospital
🇦🇺Camperdown, Australia
St Vincent's Hospital
🇦🇺Fitzroy, Australia
UZ Gent
🇧🇪Gent, Belgium
Austin Hospital
🇦🇺Heidelberg, Australia
Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen
🇧🇪Liege, Belgium
Westmead Hospital
🇦🇺Penrith, Australia
Alfred Hospital
🇦🇺Prahran, Australia
AZ Sint Jan Brugge
🇧🇪Brugge, Belgium
AZ Sint Augustinus Wilrijk
🇧🇪Wilrijk, Belgium
Fakultní nemocnice U Sv.Anny
🇨🇿Brno, Czechia
Fakultní nemocnice Olomouc
🇨🇿Olomouc, Czechia
Krajská nemocnice Pardubice
🇨🇿Pardubice, Czechia
Všeobecná fakultní nemocnice
🇨🇿Praha, Czechia
Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
🇫🇷Bron, France
Hôpital Roger Salengro
🇫🇷Lille, France
Hôpital La Timone
🇫🇷Marseille, France
Hôpital La Pitié Salpétrière
🇫🇷Paris, France
Hôpital Pasteur - CHU Nice
🇫🇷Nice, France
Hôpital Haut Lévêque
🇫🇷Pessac, France
Hôpital Purpan
🇫🇷Toulouse, France
Praxis für Neurologie
🇩🇪Neusaß, Germany
Praxis für Neurologie, International Neuroscience Institute
🇩🇪Hannover, Germany
Praxis für Neurologie und Psychatrie
🇩🇪Schorndorf, Germany
Hospital Santa Maria
🇵🇹Lisboa, Portugal
Hospital General San Antonio - Centro Hospitalar do Porto
🇵🇹Porto, Portugal
Tergooiziekenhuizen Hilversum
🇳🇱Hilversum, Netherlands
Krankenhaus der Barmherzigen Brüder
🇩🇪Trier, Germany
Martini Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Serviço de Neurologia - Hospital de São João
🇵🇹Porto, Portugal
16, ulitsa Vorovskogo
🇷🇺Chelyabinsk, Russian Federation
12a, ulitsa Karbyisheva
🇷🇺Kazan, Russian Federation
80, Volokolamskoye shossee
🇷🇺Moscow, Russian Federation
6/8, ulitsa L'va Tolstogo
🇷🇺St-Petersburg, Russian Federation
National Hospital for Neurology & Neurosurgery
🇬🇧London, United Kingdom
Walton Centre for Neurology & Neurosurgery, Hope Hospital
🇬🇧Manchester, United Kingdom
Royal Devon & Exeter Hospital
🇬🇧Exeter, United Kingdom