Phase IV-Cervical Dystonia-INTEREST IN CD2

Cervical Dystonia Clinical Trial

— INTEREST_INCD2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753349
• Other study ID #: Y-79-52120-166
• Status: Completed
• Start date: December 2012
• Est. completion date: September 25, 2017

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: September 25, 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Biological:
• Botulinum toxin type A
Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Algeria,  Australia,  Austria,  Belgium,  Brazil,  China,  Czechia,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Jordan,  Korea, Republic of,  Latvia,  Lebanon,  Malaysia,  Mexico,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovenia,  Sweden,  Taiwan,  Thailand,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	Change in tremor associated with CD using Tsui score		Baseline and at every 3 to 4 months, up to 3 years.
Secondary	Change in pain relief assessed using the TWSTRS pain sub-scale.		Baseline and at every 3 to 4 months, up to 3 years.
Secondary	Change in disability will be measured with the TWSTRS disability sub-scale.		Baseline and at every 3 to 4 months, up to 3 years.
Secondary	Pharmaco-economic endpoints	Time intervals between injections; Changes in concomitant treatments for CD and associated symptoms.; Changes in employment status	Baseline and at every 3 to 4 months, up to 3 years.