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The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic cervical dystonia | Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia. BoNT-A injections, 3-4 times yearly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in subject's satisfaction using a 5-point Likert scale. | Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD. | Baseline and at every 3 to 4 months, up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale. | Assessment of severity of CD. | Baseline and at every 3 to 4 months, up to 3 years. |
| Change in tremor associated with CD using Tsui score |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkinson's and Movement Disorders Center of Maryland | Elkridge | Maryland | 21075 | United States | ||
| Tufts Medical Center, Inc |
| 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. |
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| Baseline and at every 3 to 4 months, up to 3 years. |
| Change in pain relief assessed using the TWSTRS pain sub-scale. | Baseline and at every 3 to 4 months, up to 3 years. |
| Change in disability will be measured with the TWSTRS disability sub-scale. | Baseline and at every 3 to 4 months, up to 3 years. |
| Pharmaco-economic endpoints |
| Baseline and at every 3 to 4 months, up to 3 years. |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| The Parkinson's and Movement Disorders Center | Southfield | Michigan | 48034 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Bab El Oued Hospital | Algiers | 16009 | Algeria |
| Sidi Bel Abbes Hospital | Algiers | 22000 | Algeria |
| Ben Badis Hospital | Constantine | 25000 | Algeria |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Alfred Hospital, | Melbourne | 30004 | Australia |
| Dandenong Neurology | Melbourne | 3175 | Australia |
| Royal North Shore Hospital | Sydney | 2065 | Australia |
| Burwest Neurophysiology | Sydney | 2134 | Australia |
| Medical University of Vienna Spitalgasse 23 | Vienna | 1090 | Austria |
| AZ Sint Jan Brugge - Oostende AV | Bruges | 8000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| AZ Sint Lucas | Ghent | 9000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | 4000 | Belgium |
| Hospital das Clínicas, Universidade Federal de Minas Gerais | Belo Horizonte | 30130-100 | Brazil |
| Campus Universitario | Ribeirão Preto | 14048-900 | Brazil |
| Hospital Universitario Antoni Pedro | Rio de Janeiro | 24033-900 | Brazil |
| Instituto de Medicina Física e Reabilitaçao | São Paulo | 04116-030 | Brazil |
| Queen Mary Hospital | Hong Kong | China |
| Faculty Hospital Sv. Anna Brno | Brno | Czechia |
| Faculty hospital Olomouc | Olomouc | 775 20 | Czechia |
| Pardubice Regional Hospital, Inc. | Pardubice | 532 03 | Czechia |
| Department of Neurology 1st LF UK and VFN | Prague | 128 21 | Czechia |
| East Tallinn Central Hospital | Tallinn | 10138 | Estonia |
| Tartu University Hospital, Neurology Clinic | Tartu | 51014 | Estonia |
| Centre Hospitalier d'Albi | Albi | 81000 | France |
| CHU Amiens Nord | Amiens | 80054 | France |
| CHI Robert Ballanger | Aulnay-sous-Bois | 93602 | France |
| CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer | Bron | 69677 | France |
| Hôpital Roger Salengro | Lille | 59037 | France |
| Hôpital La Timone | Marseille | 13385 | France |
| Hopital universitaire Carémeau | Nîmes | 30029 | France |
| Hôpital Purpan | Toulouse | 31059 | France |
| Neurologische Universitätsklinik Erlangen | Erlangen | 91054 | Germany |
| Neurologische Privatpraxis | Hanover | 30627 | Germany |
| Städtisches Klinikum Karlsruhe | Karlsruhe | 76133 | Germany |
| Hauptstraße 1a | Neusaß | 86356 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Jósa András Oktató Kórház | Nyíregyháza | 4400 | Hungary |
| Carmel Medical Center Haifa Israël | Haifa | 34361 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Ospedali Riuniti di Bergamo | Bergamo | 24100 | Italy |
| Azienda Ospedaliera-Universitaria | Ferrara | 44100 | Italy |
| A.O.U. Policlinico "G. Martino | Messina | 98125 | Italy |
| II Università degli Studi di Napoli | Naples | 80131 | Italy |
| A.O. Villa Sofia CTO | Palermo | 90144 | Italy |
| Policlinico Umberto I, Università La Sapienza | Roma | 00185 | Italy |
| Università La Sapienza | Roma | 00185 | Italy |
| Ospedale Mauriziano - Umberto I | Torino | 10128 | Italy |
| Jordan Hospital | Amman | 11118 | Jordan |
| National Rehabilitation center "Vaivari" | Jūrmala | 2008, | Latvia |
| P. Stradins Clinical University hospital | Riga | 1002 | Latvia |
| Hopital Hotel Dieu | Beirut | Lebanon |
| Centre Hospitalier Universitaire Notre Dame de Secours | Byblos | Lebanon |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| University of Malaysia | Kuala Lumpur | 50603 | Malaysia |
| Centro Medico Zambrano Hellion | San Pedro Garza García | Nuevo León | 66278 | Mexico |
| Hospital General Dr. Santiago Ramón y Cajal | Durango | 34070 | Mexico |
| Hospital General de México | Mexico City | 06720 | Mexico |
| Nuevo Hospital Obregón | Mexico City | 15740 | Mexico |
| Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez" | Mexico City | Mexico |
| Centro de Rehabilitación Integral de Querétaro | Querétaro | 76090 | Mexico |
| Metropolitan Medical Center | Manila | Philippines |
| St Luke's Medical Center | Quezon | Philippines |
| Specjalistyczna Praktyka Lekarska | Katowice | 40-097 | Poland |
| Medical University of Warsaw | Warsaw | 02-097 | Poland |
| Centro Hospitalar Lisboa Norte | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar do Porto | Porto | 4099-001 | Portugal |
| Hospital São Bernardo | Setùbal | 2910-446 | Portugal |
| Centro Hospitalar de Trás-os-Montes e Alto Douro | Vila Real | 5000-508 | Portugal |
| Spitalul Universitar de Urgenta Bucuresti, neurologie | Bucharest | Sector 5050098 | Romania |
| Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II | Timișoara | 300736 | Romania |
| The Chelyabinsk state medical academy, | Chelyabinsk | 454092 | Russia |
| State Institution "Interregional clinical diagnostic centre" | Kazan' | 420101 | Russia |
| State Educational Institution of high professional education "Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky of the Ministry of Health and Social Development of Russia" | Krasnoyarsk | 660022 | Russia |
| State Federal Budgetary Institution Scientific Center of Neurology RAMS | Moscow | 125367 | Russia |
| State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" | St-Peterburg | 197022 | Russia |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| University Clinical Centre Maribor | Maribor | Slovenia |
| Dong-A University Hospital | Busan | 602-715 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
| Stortorgets Neurologmottagning | Helsingborg | 252 20 | Sweden |
| Universtitessjukhuset i Linköping | Linköping | 582 85 | Sweden |
| Skånes University Hospital | Malmö | 205 02 | Sweden |
| Neuroenheten Utsikten | Stockholm | 116 28 | Sweden |
| Norrlands Universitetssjukhus (NUS) | Umeå | 901 85 | Sweden |
| Uppsala University Hospital | Uppsala | 751 85 | Sweden |
| Kaohsiung Chang-gung Memorial Hospital | Kaohsiung City | Taiwan |
| TaiChung Veterans General Hospital | Taichung | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | Thailand |
| Siriraj Hospital | Bangkok | Thailand |
| Gazi University Medical Faculty | Ankara | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | Turkey (Türkiye) |
| Istanbul University Cerrahpaşa Medical Faculty | Istanbul | Turkey (Türkiye) |
| Dogu Mersin University Hospital | Mersin | Turkey (Türkiye) |
| Rashid Hospital | Dubai | United Arab Emirates |
| Royal Devon & Exeter Hospital | Exeter | EX2 5DW | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| Neurology, John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Queen's Hospital Romford | Romford | RM7 0AG | United Kingdom |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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