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

November 4, 2020 updated by: Ipsen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1050

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hopital 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
        • Universitatsklinikum Tubingen
      • 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
        • Hopital Hotel 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in subject's satisfaction using a 5-point Likert scale.
Time Frame: Baseline and at every 3 to 4 months, up to 3 years.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.
Time Frame: Baseline and at every 3 to 4 months, up to 3 years.
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
Time Frame: Baseline and at every 3 to 4 months, up to 3 years.
Baseline and at every 3 to 4 months, up to 3 years.
Change in pain relief assessed using the TWSTRS pain sub-scale.
Time Frame: Baseline and at every 3 to 4 months, up to 3 years.
Baseline and at every 3 to 4 months, up to 3 years.
Change in disability will be measured with the TWSTRS disability sub-scale.
Time Frame: Baseline and at every 3 to 4 months, up to 3 years.
Baseline and at every 3 to 4 months, up to 3 years.
Pharmaco-economic endpoints
Time Frame: Baseline and at every 3 to 4 months, up to 3 years.
  • 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Y-79-52120-166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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