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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice | Around 4 weeks post injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with idiopathic cervical dystonia
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | NSW 2050 | Australia | |||
| St Vincent's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34316644 | Derived | Trosch RM, Misra VP, Maisonobe P, Om S. Impact of abobotulinumtoxinA on the clinical features of cervical dystonia in routine practice. Clin Park Relat Disord. 2020 Jun 15;3:100063. doi: 10.1016/j.prdoa.2020.100063. eCollection 2020. | |
| 22700836 | Derived | Misra VP, Ehler E, Zakine B, Maisonobe P, Simonetta-Moreau M; INTEREST IN CD group. Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia: results from an international observational study. BMJ Open. 2012 Jun 14;2(3):e000881. doi: 10.1136/bmjopen-2012-000881. Print 2012. |
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| To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion | Baseline, and around 4 weeks post injection |
| To describe subject and investigator's CGI scores | Around 4 weeks post injection |
| To identify prognostic factors for response (Exploratory Objective) | baseline, and around 4 weeks and 3 months post injection |
| Fitzroy |
| VIC 3065 |
| Australia |
| Austin Hospital | Heidelberg | VIC 3084 | Australia |
| Westmead Hospital | Penrith | NSW 2751 | Australia |
| Alfred Hospital | Prahran | VIC 3181 | Australia |
| AZ Sint Jan Brugge | Bruges | 8000 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen | Liège | B 4000 | Belgium |
| AZ Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| Fakultní nemocnice U Sv.Anny | Brno | 656 91 Brno | Czechia |
| Fakultní nemocnice Olomouc | Olomouc | 775 20 Olomouc | Czechia |
| Krajská nemocnice Pardubice | Pardubice | 530 03 Pardubice | Czechia |
| Všeobecná fakultní nemocnice | Prague | 120 00 Praha 2 | Czechia |
| Hôpital Neurologique et Neurochirurgical Pierre Wertheimer | Bron | 69677 | France |
| Hôpital Roger Salengro | Lille | 59037 | France |
| Hôpital La Timone | Marseille | 13385 | France |
| Hôpital Pasteur - CHU Nice | Nice | 06002 | France |
| Hôpital La Pitié Salpétrière | Paris | 75651 | France |
| Hôpital Haut Lévêque | Pessac | 33604 | France |
| Hôpital Purpan | Toulouse | 31059 | France |
| Praxis für Neurologie | Berlin | 10178 | Germany |
| Praxis für Neurologie | Bochum | 44787 | Germany |
| Praxis für Neurologie, International Neuroscience Institute | Hanover | 30625 | Germany |
| Praxis für Neurologie | Neusaß | 86356 | Germany |
| Praxis für Neurologie und Psychatrie | Schorndorf | 73614 | Germany |
| Krankenhaus der Barmherzigen Brüder | Trier | 54929 | Germany |
| Martini Ziekenhuis Groningen | Groningen | 9728 - NZ | Netherlands |
| Tergooiziekenhuizen Hilversum | Hilversum | 1213 - XZ | Netherlands |
| Hospital Santa Maria | Lisbon | 1649-035 | Portugal |
| Hospital General San Antonio - Centro Hospitalar do Porto | Porto | 4099-001 | Portugal |
| Serviço de Neurologia - Hospital de São João | Porto | 4202-451 | Portugal |
| 16, ulitsa Vorovskogo | Chelyabinsk | 454048 | Russia |
| 12a, ulitsa Karbyisheva | Kazan' | 420101 | Russia |
| 80, Volokolamskoye shossee | Moscow | 123367 | Russia |
| 6/8, ulitsa L'va Tolstogo | Saint Petersburg | 197022 | Russia |
| Royal Devon & Exeter Hospital | Exeter | EX2 5DW | United Kingdom |
| National Hospital for Neurology & Neurosurgery | London | WC1N 3BG | United Kingdom |
| Walton Centre for Neurology & Neurosurgery, Hope Hospital | Manchester | M6 8HP | United Kingdom |