Phase IV-Cervical Dystonia-INTEREST IN CD2
- Conditions
- Cervical Dystonia
- Interventions
- Biological: Botulinum toxin type A
- Registration Number
- NCT01753349
- Lead Sponsor
- Ipsen
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1050
- Subject for whom there is an intention to treat with BoNT-A.
- BoNT treatment naïve or previously treated with BoNT.
- If previously treated with BoNT, at least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion.
- Subject able to comply with the protocol.
- Provision of written informed consent prior to collect the data.
- Contraindications to any BoNT-A preparations.
- The subject has already been included in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Idiopathic cervical dystonia Botulinum toxin type A Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia. BoNT-A injections, 3-4 times yearly.
- Primary Outcome Measures
Name Time Method Change in subject's satisfaction using a 5-point Likert scale. Baseline and at every 3 to 4 months, up to 3 years. Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.
- Secondary Outcome Measures
Name Time Method Change in tremor associated with CD using Tsui score 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. Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale. Baseline and at every 3 to 4 months, up to 3 years. Assessment of severity of CD.
Change in pain relief assessed using the TWSTRS pain 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. * Time intervals between injections
* Changes in concomitant treatments for CD and associated symptoms.
* Changes in employment status
Trial Locations
- Locations (113)
Tel Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Jósa András Oktató Kórház
🇭🇺Nyíregyháza, Hungary
Centro Hospitalar Lisboa Norte
🇵🇹Lisbon, Portugal
Hospital São Bernardo
🇵🇹Setùbal, Portugal
Hopital Hotel Dieu
🇱🇧Beirut, Lebanon
Hospital General Dr. Santiago Ramón y Cajal
🇲🇽Durango, Mexico
Centro Hospitalar de Trás-os-Montes e Alto Douro
🇵🇹Vila Real, Portugal
Spitalul Universitar de Urgenta Bucuresti, neurologie
🇷🇴Bucuresti, Romania
Military Medical Academy
🇷🇸Belgrade, Serbia
State Institution "Interregional clinical diagnostic centre"
🇷🇺Kazan, Russian Federation
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, Russian Federation
Ospedale Mauriziano - Umberto I
🇮🇹Torino, Italy
Hospital das Clínicas, Universidade Federal de Minas Gerais
🇧🇷Belo Horizonte, Brazil
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Jordan Hospital
🇯🇴Amman, Jordan
Azienda Ospedaliera-Universitaria
🇮🇹Ferrara, Italy
Policlinico Umberto I, Università La Sapienza
🇮🇹Roma, Italy
A.O.U. Policlinico "G. Martino
🇮🇹Messina, Italy
II Università degli Studi di Napoli
🇮🇹Napoli, Italy
A.O. Villa Sofia CTO
🇮🇹Palermo, Italy
Carmel Medical Center Haifa Israël
🇮🇱Haifa, Israel
Università La Sapienza
🇮🇹Roma, Italy
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
St Luke's Medical Center
🇵🇭Quezon, Philippines
Metropolitan Medical Center
🇵🇭Manila, Philippines
Norrlands Universitetssjukhus (NUS)
🇸🇪Umeå, Sweden
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Skånes University Hospital
🇸🇪Malmö, Sweden
Neuroenheten Utsikten
🇸🇪Stockholm, Sweden
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Istanbul University Cerrahpaşa Medical Faculty
🇹🇷Istanbul, Turkey
Rashid Hospital
🇦🇪Dubai, United Arab Emirates
Royal Devon & Exeter Hospital
🇬🇧Exeter, United Kingdom
Neurology, John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Queen's Hospital Romford
🇬🇧Romford, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-Do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Parkinson's and Movement Disorders Center of Maryland
🇺🇸Elkridge, Maryland, United States
Tufts Medical Center, Inc
🇺🇸Boston, Massachusetts, United States
The Parkinson's and Movement Disorders Center
🇺🇸Southfield, Michigan, United States
Ben Badis Hospital
🇩🇿Constantine, Algeria
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Dandenong Neurology
🇦🇺Melbourne, Australia
Alfred Hospital,
🇦🇺Melbourne, Australia
Burwest Neurophysiology
🇦🇺Sydney, Australia
Royal North Shore Hospital
🇦🇺Sydney, Australia
AZ Sint Jan Brugge - Oostende AV
🇧🇪Brugge, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Medical University of Vienna Spitalgasse 23
🇦🇹Vienna, Austria
AZ Sint Lucas
🇧🇪Gent, Belgium
Campus Universitario
🇧🇷Ribeirão Preto, Brazil
Hospital Universitario Antoni Pedro
🇧🇷Rio De Janeiro, Brazil
Instituto de Medicina Física e Reabilitaçao
🇧🇷Sao Paulo, Brazil
Queen Mary Hospital
🇨🇳Hong Kong, China
Faculty hospital Olomouc
🇨🇿Olomouc, Czechia
Faculty Hospital Sv. Anna Brno
🇨🇿Brno, Czechia
Pardubice Regional Hospital, Inc.
🇨🇿Pardubice, Czechia
East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Department of Neurology 1st LF UK and VFN
🇨🇿Prague, Czechia
Centre Hospitalier d'Albi
🇫🇷Albi, France
CHI Robert Ballanger
🇫🇷Aulnay/sous Bois cedex, France
CHU Amiens Nord
🇫🇷Amiens Cedex 1, France
CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
🇫🇷Bron Cedex, France
Hôpital Roger Salengro
🇫🇷Lille cedex, France
Hopital universitaire Carémeau
🇫🇷Nimes cedex 09, France
Hôpital La Timone
🇫🇷Marseille Cedex, France
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Hôpital Purpan
🇫🇷Toulouse Cedex 9, France
Neurologische Privatpraxis
🇩🇪Hannover, Germany
Neurologische Universitätsklinik Erlangen
🇩🇪Erlangen, Germany
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
Hauptstraße 1a
🇩🇪Neusaß, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Nuevo Hospital Obregón
🇲🇽Mexico City, Mexico
Hospital General de México
🇲🇽Mexico City, Mexico
Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez"
🇲🇽Mexico City, Mexico
Centro de Rehabilitación Integral de Querétaro
🇲🇽Querétaro, Mexico
The Chelyabinsk state medical academy,
🇷🇺Chelyabinsk, Russian Federation
Stortorgets Neurologmottagning
🇸🇪Helsingborg, Sweden
Universtitessjukhuset i Linköping
🇸🇪Linköping, Sweden
Dogu Mersin University Hospital
🇹🇷Mersin, Turkey
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
Tartu University Hospital, Neurology Clinic
🇪🇪Tartu, Estonia
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Centro Medico Zambrano Hellion
🇲🇽San Pedro Garza Garcia, Nuevo Leon, Mexico
Centro Hospitalar do Porto
🇵🇹Porto, Portugal
Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II
🇷🇴Timisoara, Romania
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Singapore General Hospital
🇸🇬Singapore, Singapore
Bab El Oued Hospital
🇩🇿Alger, Algeria
Sidi Bel Abbes Hospital
🇩🇿Alger, Algeria
National Rehabilitation center "Vaivari"
🇱🇻Jurmala, Latvia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Specjalistyczna Praktyka Lekarska
🇵🇱Katowice, Poland
P. Stradins Clinical University hospital
🇱🇻Riga, Latvia
Centre Hospitalier Universitaire Notre Dame de Secours
🇱🇧Jbaïl, Lebanon
University of Malaysia
🇲🇾Kuala Lumpur, Malaysia
Medical University of Warsaw
🇵🇱Warsaw, Poland
State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav"
🇷🇺St-Peterburg, Russian Federation
University Medical Centre Ljubljana
🇸🇮Ljubljana, Slovenia
University Clinical Centre Maribor
🇸🇮Maribor, Slovenia
Kaohsiung Chang-gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
TaiChung Veterans General Hospital
🇨🇳Taichung, Taiwan
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
Siriraj Hospital
🇹🇭Bangkok, Thailand
State Federal Budgetary Institution Scientific Center of Neurology RAMS
🇷🇺Moscow, Russian Federation