Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

August 14, 2019 updated by: Ipsen

An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

404

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

  • Australia
      • Camperdown, Australia, NSW 2050
        • Royal Prince Alfred Hospital
      • Fitzroy, Australia, VIC 3065
        • St Vincent's Hospital
      • Heidelberg, Australia, VIC 3084
        • Austin Hospital
      • Penrith, Australia, NSW 2751
        • Westmead Hospital
      • Prahran, Australia, VIC 3181
        • Alfred Hospital
  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint Jan Brugge
      • Gent, Belgium, 9000
        • Uz Gent
      • Leuven, Belgium, 3000
      • Liege, Belgium, B 4000
        • Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen
      • Wilrijk, Belgium, 2610
        • AZ Sint Augustinus Wilrijk
  • Czechia
      • Brno, Czechia, 656 91 Brno
        • Fakultní nemocnice U Sv.Anny
      • Olomouc, Czechia, 775 20 Olomouc
        • Fakultni nemocnice Olomouc
      • Pardubice, Czechia, 530 03 Pardubice
        • Krajská nemocnice Pardubice
      • Praha, Czechia, 120 00 Praha 2
        • Vseobecna Fakultni Nemocnice
  • France
      • Bron, France, 69677
        • Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
      • Lille, France, 59037
        • Hôpital Roger Salengro
      • Marseille, France, 13385
        • Hôpital La Timone
      • Nice, France, 06002
        • Hôpital Pasteur - CHU Nice
      • Paris, France, 75651
        • Hôpital La Pitié Salpêtrière
      • Pessac, France, 33604
        • Hopital Haut Leveque
      • Toulouse, France, 31059
        • Hopital Purpan
  • Germany
      • Berlin, Germany, 10178
        • Praxis für Neurologie
      • Bochum, Germany, 44787
        • Praxis für Neurologie
      • Hannover, Germany, 30625
        • Praxis für Neurologie, International Neuroscience Institute
      • Neusaß, Germany, 86356
        • Praxis für Neurologie
      • Schorndorf, Germany, 73614
        • Praxis für Neurologie und Psychatrie
      • Trier, Germany, 54929
        • Krankenhaus der Barmherzigen Brüder
  • Netherlands
      • Groningen, Netherlands, 9728 - NZ
        • Martini Ziekenhuis Groningen
      • Hilversum, Netherlands, 1213 - XZ
        • Tergooiziekenhuizen Hilversum
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Hospital Santa Maria
      • Porto, Portugal, 4099-001
        • Hospital General San Antonio - Centro Hospitalar do Porto
      • Porto, Portugal, 4202-451
        • Serviço de Neurologia - Hospital de São João
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
        • 16, ulitsa Vorovskogo
      • Kazan, Russian Federation, 420101
        • 12a, ulitsa Karbyisheva
      • Moscow, Russian Federation, 123367
        • 80, Volokolamskoye shossee
      • St-Petersburg, Russian Federation, 197022
        • 6/8, ulitsa L'va Tolstogo
  • United Kingdom
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital
      • London, United Kingdom, WC1N 3BG
        • National Hospital for Neurology & Neurosurgery
      • Manchester, United Kingdom, M6 8HP
        • Walton Centre for Neurology & Neurosurgery, Hope Hospital

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

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

Patients with idiopathic cervical dystonia

Description

Inclusion Criteria:

  • Idiopathic cervical dystonia
  • TWSTRS severity score ≥ 15
  • At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion
  • Written informed consent prior to collect the data

Exclusion Criteria:

  • Contraindications to any BoNT-A preparations
  • Secondary cervical dystonia
  • Subject 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
Time Frame: Around 4 weeks post injection
Around 4 weeks post injection

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe TWSTRS change scores from inclusion (total score & subscales scores)
Time Frame: Baseline, and around 4 weeks and 3 months post injection
Baseline, and around 4 weeks and 3 months post injection
To describe tremor change score from inclusion (TSUI scale)
Time Frame: Baseline, and around 4 weeks and 3 months post injection
Baseline, and around 4 weeks and 3 months post injection
To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion
Time Frame: Baseline, and around 4 weeks post injection
Baseline, and around 4 weeks post injection
To describe subject and investigator's CGI scores
Time Frame: Around 4 weeks post injection
Around 4 weeks post injection
To identify prognostic factors for response (Exploratory Objective)
Time Frame: baseline, and around 4 weeks and 3 months post injection
baseline, and around 4 weeks and 3 months post injection

Collaborators and Investigators

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

Sponsor

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

February 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y-79-52120-131

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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