Phase IV-Cervical Dystonia-INTEREST IN CD2 (INTEREST_INCD2)

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

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).

Study Overview

• Status: Completed
• Conditions: Cervical Dystonia
• Intervention / Treatment: Biological: Botulinum toxin type A

• Study Type: Observational
• Enrollment (Actual): 1050

Contacts and Locations

Study Locations

• Algeria
  • Alger, Algeria, 16009
    • Bab El Oued Hospital
  • Alger, Algeria, 22000
    • Sidi Bel Abbes Hospital
  • Constantine, Algeria, 25000
    • Ben Badis Hospital
• Australia
  • Melbourne, Australia, 30004
    • Alfred Hospital,
  • Melbourne, Australia, 3175
    • Dandenong Neurology
  • Sydney, Australia, 2065
    • Royal North Shore Hospital
  • Sydney, Australia, 2134
    • Burwest Neurophysiology
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital
• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna Spitalgasse 23
• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint Jan Brugge - Oostende AV
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Gent, Belgium, 9000
    • Az Sint Lucas
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege
• Brazil
  • Belo Horizonte, Brazil, 30130-100
    • Hospital das Clínicas, Universidade Federal de Minas Gerais
  • Ribeirão Preto, Brazil, 14048-900
    • Campus Universitario
  • Rio De Janeiro, Brazil, 24033-900
    • Hospital Universitario Antoni Pedro
  • Sao Paulo, Brazil, 04116-030
    • Instituto de Medicina Física e Reabilitaçao
• China
  • Hong Kong, China
    • Queen Mary Hospital
• Czechia
  • Brno, Czechia
    • Faculty Hospital Sv. Anna Brno
  • Olomouc, Czechia, 775 20
    • Faculty Hospital Olomouc
  • Pardubice, Czechia, 532 03
    • Pardubice Regional Hospital, Inc.
  • Prague, Czechia, 128 21
    • Department of Neurology 1st LF UK and VFN
• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital
  • Tartu, Estonia, 51014
    • Tartu University Hospital, Neurology Clinic
• France
  • Albi, France, 81000
    • Centre Hospitalier D'Albi
  • Amiens Cedex 1, France, 80054
    • CHU Amiens Nord
  • Aulnay/sous Bois cedex, France, 93602
    • CHI Robert Ballanger
  • Bron Cedex, France, 69677
    • CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
  • Lille cedex, France, 59037
    • Hôpital Roger Salengro
  • Marseille Cedex, France, 13385
    • Hôpital la Timone
  • Nimes cedex 09, France, 30029
    • Hopital Universitaire Caremeau
  • Toulouse Cedex 9, France, 31059
    • Hopital Purpan
• Germany
  • Erlangen, Germany, 91054
    • Neurologische Universitätsklinik Erlangen
  • Hannover, Germany, 30627
    • Neurologische Privatpraxis
  • Karlsruhe, Germany, 76133
    • Stadtisches Klinikum Karlsruhe
  • Neusaß, Germany, 86356
    • Hauptstraße 1a
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Nyíregyháza, Hungary, 4400
    • Jósa András Oktató Kórház
• Israel
  • Haifa, Israel, 34361
    • Carmel Medical Center Haifa Israël
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
  • Tel-Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bergamo, Italy, 24100
    • Ospedali Riuniti di Bergamo
  • Ferrara, Italy, 44100
    • Azienda Ospedaliera-Universitaria
  • Messina, Italy, 98125
    • A.O.U. Policlinico "G. Martino
  • Napoli, Italy, 80131
    • II Universita degli Studi di Napoli
  • Palermo, Italy, 90144
    • A.O. Villa Sofia CTO
  • Roma, Italy, 00185
    • Università La Sapienza
  • Roma, Italy, 00185
    • Policlinico Umberto I, Università La Sapienza
  • Torino, Italy, 10128
    • Ospedale Mauriziano - Umberto I
• Jordan
  • Amman, Jordan, 11118
    • Jordan Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 602-715
    • Dong-A University Hospital
  • Gyeonggi-Do, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital
• Latvia
  • Jurmala, Latvia, 2008,
    • National Rehabilitation center "Vaivari"
  • Riga, Latvia, 1002
    • P. Stradins Clinical University Hospital
• Lebanon
  • Beirut, Lebanon
    • Hôpital Hôtel Dieu
  • Jbaïl, Lebanon
    • Centre Hospitalier universitaire Notre Dame de secours
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia, 50603
    • University of Malaysia
• Mexico
  • Durango, Mexico, 34070
    • Hospital General Dr. Santiago Ramón y Cajal
  • Mexico City, Mexico, 06720
    • Hospital General de Mexico
  • Mexico City, Mexico, 15740
    • Nuevo Hospital Obregón
  • Mexico City, Mexico
    • Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suarez"
  • Querétaro, Mexico, 76090
    • Centro de Rehabilitación Integral de Querétaro
  • Nuevo Leon
    • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
      • Centro Médico Zambrano Hellion
• Philippines
  • Manila, Philippines
    • Metropolitan Medical Center
  • Quezon, Philippines
    • St Luke's Medical Center
• Poland
  • Katowice, Poland, 40-097
    • Specjalistyczna Praktyka Lekarska
  • Warsaw, Poland, 02-097
    • Medical University of Warsaw
• Portugal
  • Lisbon, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto
  • Setùbal, Portugal, 2910-446
    • Hospital São Bernardo
  • Vila Real, Portugal, 5000-508
    • Centro Hospitalar de Tras-os-Montes e Alto Douro
• Romania
  • Bucuresti, Romania, Sector 5050098
    • Spitalul Universitar de Urgenta Bucuresti, neurologie
  • Timisoara, Romania, 300736
    • Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II
• Russian Federation
  • Chelyabinsk, Russian Federation, 454092
    • The Chelyabinsk state medical academy,
  • Kazan, Russian Federation, 420101
    • State Institution "Interregional clinical diagnostic centre"
  • Krasnoyarsk, Russian Federation, 660022
    • 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"
  • Moscow, Russian Federation, 125367
    • State Federal Budgetary Institution Scientific Center of Neurology RAMS
  • St-Peterburg, Russian Federation, 197022
    • State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav"
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana
  • Maribor, Slovenia
    • University Clinical Centre Maribor
• Sweden
  • Helsingborg, Sweden, 252 20
    • Stortorgets neurologmottagning
  • Linköping, Sweden, 582 85
    • Universtitessjukhuset i Linköping
  • Malmö, Sweden, 205 02
    • Skånes University Hospital
  • Stockholm, Sweden, 116 28
    • Neuroenheten Utsikten
  • Umeå, Sweden, 901 85
    • Norrlands Universitetssjukhus (NUS)
  • Uppsala, Sweden, 751 85
    • Uppsala University Hospital
• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Chang-Gung Memorial Hospital
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
• Thailand
  • Bangkok, Thailand
    • Siriraj Hospital
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital
• Turkey
  • Ankara, Turkey
    • Gazi University Medical Faculty
  • Ankara, Turkey
    • Hacettepe University Medical Faculty
  • Istanbul, Turkey
    • Istanbul University Cerrahpasa Medical Faculty
  • Mersin, Turkey
    • Dogu Mersin University Hospital
• United Arab Emirates
  • Dubai, United Arab Emirates
    • Rashid Hospital
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon & Exeter Hospital
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • Oxford, United Kingdom, OX3 9DU
    • Neurology, John Radcliffe Hospital
  • Romford, United Kingdom, RM7 0AG
    • Queen's Hospital Romford
• United States
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Parkinson's and Movement Disorders Center of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center, Inc
  • Michigan
    • Southfield, Michigan, United States, 48034
      • The Parkinson's and Movement Disorders Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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	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.

Collaborators and Investigators

• Sponsor: Ipsen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 25, 2017

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Torticollis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: Y-79-52120-166