Phase IV-Cervical Dystonia-INTEREST IN CD2

NCT ID: NCT01753349

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1050 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-09-25

Brief Summary

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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).

Detailed Description

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Conditions

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Cervical Dystonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic cervical dystonia

Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia. BoNT-A injections, 3-4 times yearly.

Botulinum toxin type A

Intervention Type BIOLOGICAL

Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.

Interventions

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Botulinum toxin type A

Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Parkinson's and Movement Disorders Center of Maryland

Elkridge, Maryland, United States

Site Status

Tufts Medical Center, Inc

Boston, Massachusetts, United States

Site Status

The Parkinson's and Movement Disorders Center

Southfield, Michigan, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Bab El Oued Hospital

Algiers, , Algeria

Site Status

Sidi Bel Abbes Hospital

Algiers, , Algeria

Site Status

Ben Badis Hospital

Constantine, , Algeria

Site Status

Austin Hospital

Heidelberg, Victoria, Australia

Site Status

Alfred Hospital,

Melbourne, , Australia

Site Status

Dandenong Neurology

Melbourne, , Australia

Site Status

Royal North Shore Hospital

Sydney, , Australia

Site Status

Burwest Neurophysiology

Sydney, , Australia

Site Status

Medical University of Vienna Spitalgasse 23

Vienna, , Austria

Site Status

AZ Sint Jan Brugge - Oostende AV

Bruges, , Belgium

Site Status

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status

AZ Sint Lucas

Ghent, , Belgium

Site Status

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Site Status

Hospital das Clínicas, Universidade Federal de Minas Gerais

Belo Horizonte, , Brazil

Site Status

Campus Universitario

Ribeirão Preto, , Brazil

Site Status

Hospital Universitario Antoni Pedro

Rio de Janeiro, , Brazil

Site Status

Instituto de Medicina Física e Reabilitaçao

São Paulo, , Brazil

Site Status

Queen Mary Hospital

Hong Kong, , China

Site Status

Faculty Hospital Sv. Anna Brno

Brno, , Czechia

Site Status

Faculty hospital Olomouc

Olomouc, , Czechia

Site Status

Pardubice Regional Hospital, Inc.

Pardubice, , Czechia

Site Status

Department of Neurology 1st LF UK and VFN

Prague, , Czechia

Site Status

East Tallinn Central Hospital

Tallinn, , Estonia

Site Status

Tartu University Hospital, Neurology Clinic

Tartu, , Estonia

Site Status

Centre Hospitalier d'Albi

Albi, , France

Site Status

CHU Amiens Nord

Amiens, , France

Site Status

CHI Robert Ballanger

Aulnay-sous-Bois, , France

Site Status

CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer

Bron, , France

Site Status

Hôpital Roger Salengro

Lille, , France

Site Status

Hôpital La Timone

Marseille, , France

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Hopital universitaire Carémeau

Nîmes, , France

Site Status

Hôpital Purpan

Toulouse, , France

Site Status

Neurologische Universitätsklinik Erlangen

Erlangen, , Germany

Site Status

Neurologische Privatpraxis

Hanover, , Germany

Site Status

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Site Status

Hauptstraße 1a

Neusaß, , Germany

Site Status

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status

Semmelweis Egyetem

Budapest, , Hungary

Site Status

Jósa András Oktató Kórház

Nyíregyháza, , Hungary

Site Status

Carmel Medical Center Haifa Israël

Haifa, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

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Ospedali Riuniti di Bergamo

Bergamo, , Italy

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Azienda Ospedaliera-Universitaria

Ferrara, , Italy

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A.O.U. Policlinico "G. Martino

Messina, , Italy

Site Status

II Università degli Studi di Napoli

Napoli, , Italy

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A.O. Villa Sofia CTO

Palermo, , Italy

Site Status

Policlinico Umberto I, Università La Sapienza

Roma, , Italy

Site Status

Università La Sapienza

Roma, , Italy

Site Status

Ospedale Mauriziano - Umberto I

Torino, , Italy

Site Status

Jordan Hospital

Amman, , Jordan

Site Status

National Rehabilitation center "Vaivari"

Jūrmala, , Latvia

Site Status

P. Stradins Clinical University hospital

Riga, , Latvia

Site Status

Hopital Hotel Dieu

Beirut, , Lebanon

Site Status

Centre Hospitalier Universitaire Notre Dame de Secours

Byblos, , Lebanon

Site Status

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status

University of Malaysia

Kuala Lumpur, , Malaysia

Site Status

Centro Medico Zambrano Hellion

San Pedro Garza García, Nuevo León, Mexico

Site Status

Hospital General Dr. Santiago Ramón y Cajal

Durango, , Mexico

Site Status

Hospital General de México

Mexico City, , Mexico

Site Status

Nuevo Hospital Obregón

Mexico City, , Mexico

Site Status

Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez"

Mexico City, , Mexico

Site Status

Centro de Rehabilitación Integral de Querétaro

Querétaro, , Mexico

Site Status

Metropolitan Medical Center

Manila, , Philippines

Site Status

St Luke's Medical Center

Quezon, , Philippines

Site Status

Specjalistyczna Praktyka Lekarska

Katowice, , Poland

Site Status

Medical University of Warsaw

Warsaw, , Poland

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Centro Hospitalar Lisboa Norte

Lisbon, , Portugal

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Centro Hospitalar do Porto

Porto, , Portugal

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Hospital São Bernardo

Setùbal, , Portugal

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Centro Hospitalar de Trás-os-Montes e Alto Douro

Vila Real, , Portugal

Site Status

Spitalul Universitar de Urgenta Bucuresti, neurologie

Bucharest, , Romania

Site Status

Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II

Timișoara, , Romania

Site Status

The Chelyabinsk state medical academy,

Chelyabinsk, , Russia

Site Status

State Institution "Interregional clinical diagnostic centre"

Kazan', , Russia

Site Status

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, , Russia

Site Status

State Federal Budgetary Institution Scientific Center of Neurology RAMS

Moscow, , Russia

Site Status

State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav"

St-Peterburg, , Russia

Site Status

Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Military Medical Academy

Belgrade, , Serbia

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Singapore General Hospital

Singapore, , Singapore

Site Status

University Medical Centre Ljubljana

Ljubljana, , Slovenia

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University Clinical Centre Maribor

Maribor, , Slovenia

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Dong-A University Hospital

Busan, , South Korea

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Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

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Seoul National University Hospital

Seoul, , South Korea

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Severance Hospital

Seoul, , South Korea

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Pusan National University Yangsan Hospital

Yangsan, , South Korea

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Stortorgets Neurologmottagning

Helsingborg, , Sweden

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Universtitessjukhuset i Linköping

Linköping, , Sweden

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Skånes University Hospital

Malmo, , Sweden

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Neuroenheten Utsikten

Stockholm, , Sweden

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Norrlands Universitetssjukhus (NUS)

Umeå, , Sweden

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Uppsala University Hospital

Uppsala, , Sweden

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Kaohsiung Chang-gung Memorial Hospital

Kaohsiung City, , Taiwan

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TaiChung Veterans General Hospital

Taichung, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

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King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

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Siriraj Hospital

Bangkok, , Thailand

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Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Istanbul University Cerrahpaşa Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Dogu Mersin University Hospital

Mersin, , Turkey (Türkiye)

Site Status

Rashid Hospital

Dubai, , United Arab Emirates

Site Status

Royal Devon & Exeter Hospital

Exeter, , United Kingdom

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Neurology, John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Queen's Hospital Romford

Romford, , United Kingdom

Site Status

Countries

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United States Algeria Australia Austria Belgium Brazil China Czechia Estonia France Germany Hungary Israel Italy Jordan Latvia Lebanon Malaysia Mexico Philippines Poland Portugal Romania Russia Serbia Singapore Slovenia South Korea Sweden Taiwan Thailand Turkey (Türkiye) United Arab Emirates United Kingdom

References

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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.

Reference Type DERIVED
PMID: 34316644 (View on PubMed)

Other Identifiers

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Y-79-52120-166

Identifier Type: -

Identifier Source: org_study_id