Phase IV-Cervical Dystonia-INTEREST IN CD2

NCT01753349 | Completed

• 1 other identifier: Y-79-52120-166
• Study Type: observational
• Target: 1,050
• Locations: 32 countries
• Sites: 110

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).

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• Change in tremor associated with CD using Tsui score

  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.

Study Arms (1)

Idiopathic cervical dystonia

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

Biological: Botulinum toxin type A

Interventions

Botulinum toxin type A BIOLOGICAL

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

Idiopathic cervical dystonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.

You may qualify if:

• Subject for whom there is an intention to treat with BoNT-A.
• BoNT treatment naïve or previously treated with BoNT.
• Subject able to comply with the protocol.
• Provision of written informed consent prior to collect the data.

You may not qualify if:

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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (113)

Parkinson's and Movement Disorders Center of Maryland

Elkridge, Maryland, 21075, United States

Location

Tufts Medical Center, Inc

Boston, Massachusetts, 02111, United States

Location

The Parkinson's and Movement Disorders Center

Southfield, Michigan, 48034, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Bab El Oued Hospital

Algiers, 16009, Algeria

Location

Sidi Bel Abbes Hospital

Algiers, 22000, Algeria

Location

Ben Badis Hospital

Constantine, 25000, Algeria

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Alfred Hospital,

Melbourne, 30004, Australia

Location

Dandenong Neurology

Melbourne, 3175, Australia

Location

Royal North Shore Hospital

Sydney, 2065, Australia

Location

Burwest Neurophysiology

Sydney, 2134, Australia

Location

Medical University of Vienna Spitalgasse 23

Vienna, 1090, Austria

Location

AZ Sint Jan Brugge - Oostende AV

Bruges, 8000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

AZ Sint Lucas

Ghent, 9000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Hospital das Clínicas, Universidade Federal de Minas Gerais

Belo Horizonte, 30130-100, Brazil

Location

Campus Universitario

Ribeirão Preto, 14048-900, Brazil

Location

Hospital Universitario Antoni Pedro

Rio de Janeiro, 24033-900, Brazil

Location

Instituto de Medicina Física e Reabilitaçao

São Paulo, 04116-030, Brazil

Location

Queen Mary Hospital

Hong Kong, China

Location

Faculty Hospital Sv. Anna Brno

Brno, Czechia

Location

Faculty hospital Olomouc

Olomouc, 775 20, Czechia

Location

Pardubice Regional Hospital, Inc.

Pardubice, 532 03, Czechia

Location

Department of Neurology 1st LF UK and VFN

Prague, 128 21, Czechia

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

Tartu University Hospital, Neurology Clinic

Tartu, 51014, Estonia

Location

Centre Hospitalier d'Albi

Albi, 81000, France

Location

CHU Amiens Nord

Amiens, 80054, France

Location

CHI Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer

Bron, 69677, France

Location

Hôpital Roger Salengro

Lille, 59037, France

Location

Hôpital La Timone

Marseille, 13385, France

Location

Hopital universitaire Carémeau

Nîmes, 30029, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

Neurologische Universitätsklinik Erlangen

Erlangen, 91054, Germany

Location

Neurologische Privatpraxis

Hanover, 30627, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Hauptstraße 1a

Neusaß, 86356, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Jósa András Oktató Kórház

Nyíregyháza, 4400, Hungary

Location

Carmel Medical Center Haifa Israël

Haifa, 34361, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

Azienda Ospedaliera-Universitaria

Ferrara, 44100, Italy

Location

A.O.U. Policlinico "G. Martino

Messina, 98125, Italy

Location

II Università degli Studi di Napoli

Napoli, 80131, Italy

Location

A.O. Villa Sofia CTO

Palermo, 90144, Italy

Location

Policlinico Umberto I, Università La Sapienza

Roma, 00185, Italy

Location

Università La Sapienza

Roma, 00185, Italy

Location

Ospedale Mauriziano - Umberto I

Torino, 10128, Italy

Location

Jordan Hospital

Amman, 11118, Jordan

Location

National Rehabilitation center "Vaivari"

Jūrmala, 2008,, Latvia

Location

P. Stradins Clinical University hospital

Riga, 1002, Latvia

Location

Hopital Hotel Dieu

Beirut, Lebanon

Location

Centre Hospitalier Universitaire Notre Dame de Secours

Byblos, Lebanon

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

University of Malaysia

Kuala Lumpur, 50603, Malaysia

Location

Centro Medico Zambrano Hellion

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Hospital General Dr. Santiago Ramón y Cajal

Durango, 34070, Mexico

Location

Hospital General de México

Mexico City, 06720, Mexico

Location

Nuevo Hospital Obregón

Mexico City, 15740, Mexico

Location

Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez"

Mexico City, Mexico

Location

Centro de Rehabilitación Integral de Querétaro

Querétaro, 76090, Mexico

Location

Metropolitan Medical Center

Manila, Philippines

Location

St Luke's Medical Center

Quezon, Philippines

Location

Specjalistyczna Praktyka Lekarska

Katowice, 40-097, Poland

Location

Medical University of Warsaw

Warsaw, 02-097, Poland

Location

Centro Hospitalar Lisboa Norte

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

Hospital São Bernardo

Setùbal, 2910-446, Portugal

Location

Centro Hospitalar de Trás-os-Montes e Alto Douro

Vila Real, 5000-508, Portugal

Location

Spitalul Universitar de Urgenta Bucuresti, neurologie

Bucharest, Sector 5050098, Romania

Location

Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II

Timișoara, 300736, Romania

Location

The Chelyabinsk state medical academy,

Chelyabinsk, 454092, Russia

Location

State Institution "Interregional clinical diagnostic centre"

Kazan', 420101, Russia

Location

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

Location

State Federal Budgetary Institution Scientific Center of Neurology RAMS

Moscow, 125367, Russia

Location

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

St-Peterburg, 197022, Russia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

University Clinical Centre Maribor

Maribor, Slovenia

Location

Dong-A University Hospital

Busan, 602-715, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

Stortorgets Neurologmottagning

Helsingborg, 252 20, Sweden

Location

Universtitessjukhuset i Linköping

Linköping, 582 85, Sweden

Location

Skånes University Hospital

Malmo, 205 02, Sweden

Location

Neuroenheten Utsikten

Stockholm, 116 28, Sweden

Location

Norrlands Universitetssjukhus (NUS)

Umeå, 901 85, Sweden

Location

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Kaohsiung Chang-gung Memorial Hospital

Kaohsiung City, Taiwan

Location

TaiChung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Istanbul University Cerrahpaşa Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Dogu Mersin University Hospital

Mersin, Turkey (Türkiye)

Location

Rashid Hospital

Dubai, United Arab Emirates

Location

Royal Devon & Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

Neurology, John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Queen's Hospital Romford

Romford, RM7 0AG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34316644 DERIVED

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 25, 2017
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

SE (6); IT (8); CN (1); JO (1); PH (2); ES (2); LE (2); PL (2); PT (4); BE (4); SG (1); TU (4); LA (2); CZ (4); AL (3); RO (2); AE (1); DE (6); BR (4); AU (5); FR (8); MY (2); IL (3); TW (3); GB (4); KR (5); HU (2); SL (2); US (4); ME (6); RU (5); TH (2)