Clinical trial NCT01753349: Phase IV-Cervical Dystonia-INTEREST IN CD2
Official title: An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Contraindications to any BoNT-A preparations.
* The subject has already been included in the study.

Primary outcomes:
measure: Change in subject's satisfaction using a 5-point Likert scale.
timeFrame: Baseline and at every 3 to 4 months, up to 3 years.
Secondary outcomes:
measure: Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.
timeFrame: Baseline and at every 3 to 4 months, up to 3 years.
measure: Change in tremor associated with CD using Tsui score
timeFrame: Baseline and at every 3 to 4 months, up to 3 years.
measure: Change in pain relief assessed using the TWSTRS pain sub-scale.
timeFrame: Baseline and at every 3 to 4 months, up to 3 years.
measure: Change in disability will be measured with the TWSTRS disability sub-scale.
timeFrame: Baseline and at every 3 to 4 months, up to 3 years.
measure: Pharmaco-economic endpoints
timeFrame: Baseline and at every 3 to 4 months, up to 3 years.
Other outcomes:
Locations:
city: Elkridge
country: United States
facility: Parkinson's and Movement Disorders Center of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center, Inc
state: Massachusetts
city: Southfield
country: United States
facility: The Parkinson's and Movement Disorders Center
state: Michigan
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Alger
country: Algeria
facility: Bab El Oued Hospital
city: Alger
country: Algeria
facility: Sidi Bel Abbes Hospital
city: Constantine
country: Algeria
facility: Ben Badis Hospital
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital,
city: Melbourne
country: Australia
facility: Dandenong Neurology
city: Sydney
country: Australia
facility: Royal North Shore Hospital
city: Sydney
country: Australia
facility: Burwest Neurophysiology
city: Vienna
country: Austria
facility: Medical University of Vienna Spitalgasse 23
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge - Oostende AV
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: AZ Sint Lucas
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas, Universidade Federal de Minas Gerais
city: Ribeirão Preto
country: Brazil
facility: Campus Universitario
city: Rio De Janeiro
country: Brazil
facility: Hospital Universitario Antoni Pedro
city: Sao Paulo
country: Brazil
facility: Instituto de Medicina Física e Reabilitaçao
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Brno
country: Czechia
facility: Faculty Hospital Sv. Anna Brno
city: Olomouc
country: Czechia
facility: Faculty hospital Olomouc
city: Pardubice
country: Czechia
facility: Pardubice Regional Hospital, Inc.
city: Prague
country: Czechia
facility: Department of Neurology 1st LF UK and VFN
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital, Neurology Clinic
city: Albi
country: France
facility: Centre Hospitalier d'Albi
city: Amiens Cedex 1
country: France
facility: CHU Amiens Nord
city: Aulnay/sous Bois cedex
country: France
facility: CHI Robert Ballanger
city: Bron Cedex
country: France
facility: CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
city: Lille cedex
country: France
facility: Hôpital Roger Salengro
city: Marseille Cedex
country: France
facility: Hôpital La Timone
city: Nimes cedex 09
country: France
facility: Hopital universitaire Carémeau
city: Toulouse Cedex 9
country: France
facility: Hôpital Purpan
city: Erlangen
country: Germany
facility: Neurologische Universitätsklinik Erlangen
city: Hannover
country: Germany
facility: Neurologische Privatpraxis
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Neusaß
country: Germany
facility: Hauptstraße 1a
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Nyíregyháza
country: Hungary
facility: Jósa András Oktató Kórház
city: Haifa
country: Israel
facility: Carmel Medical Center Haifa Israël
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Ferrara
country: Italy
facility: Azienda Ospedaliera-Universitaria
city: Messina
country: Italy
facility: A.O.U. Policlinico "G. Martino
city: Napoli
country: Italy
facility: II Università degli Studi di Napoli
city: Palermo
country: Italy
facility: A.O. Villa Sofia CTO
city: Roma
country: Italy
facility: Policlinico Umberto I, Università La Sapienza
city: Roma
country: Italy
facility: Università La Sapienza
city: Torino
country: Italy
facility: Ospedale Mauriziano - Umberto I
city: Amman
country: Jordan
facility: Jordan Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Gyeonggi-Do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Jurmala
country: Latvia
facility: National Rehabilitation center "Vaivari"
city: Riga
country: Latvia
facility: P. Stradins Clinical University hospital
city: Beirut
country: Lebanon
facility: Hopital Hotel Dieu
city: Jbaïl
country: Lebanon
facility: Centre Hospitalier Universitaire Notre Dame de Secours
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University of Malaysia
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Medico Zambrano Hellion
state: Nuevo Leon
city: Durango
country: Mexico
facility: Hospital General Dr. Santiago Ramón y Cajal
city: Mexico City
country: Mexico
facility: Hospital General de México
city: Mexico City
country: Mexico
facility: Nuevo Hospital Obregón
city: Mexico City
country: Mexico
facility: Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez"
city: Querétaro
country: Mexico
facility: Centro de Rehabilitación Integral de Querétaro
city: Manila
country: Philippines
facility: Metropolitan Medical Center
city: Quezon
country: Philippines
facility: St Luke's Medical Center
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
city: Setùbal
country: Portugal
facility: Hospital São Bernardo
city: Vila Real
country: Portugal
facility: Centro Hospitalar de Trás-os-Montes e Alto Douro
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti, neurologie
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II
city: Chelyabinsk
country: Russian Federation
facility: The Chelyabinsk state medical academy,
city: Kazan
country: Russian Federation
facility: State Institution "Interregional clinical diagnostic centre"
city: Krasnoyarsk
country: Russian Federation
facility: 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"
city: Moscow
country: Russian Federation
facility: State Federal Budgetary Institution Scientific Center of Neurology RAMS
city: St-Peterburg
country: Russian Federation
facility: State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav"
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Maribor
country: Slovenia
facility: University Clinical Centre Maribor
city: Helsingborg
country: Sweden
facility: Stortorgets Neurologmottagning
city: Linköping
country: Sweden
facility: Universtitessjukhuset i Linköping
city: Malmö
country: Sweden
facility: Skånes University Hospital
city: Stockholm
country: Sweden
facility: Neuroenheten Utsikten
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus (NUS)
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang-gung Memorial Hospital
city: Taichung
country: Taiwan
facility: TaiChung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpaşa Medical Faculty
city: Mersin
country: Turkey
facility: Dogu Mersin University Hospital
city: Dubai
country: United Arab Emirates
facility: Rashid Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Oxford
country: United Kingdom
facility: Neurology, John Radcliffe Hospital
city: Romford
country: United Kingdom
facility: Queen's Hospital Romford
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.