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

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.

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.
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 Fakultní 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 salpètrière
      • Pessac, France, 33604
        • Hôpital Haut Levêque
      • 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

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

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

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
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

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
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

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

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.
February 1, 2009

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.
February 1, 2010

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.
April 1, 2010

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).
January 29, 2009

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.
January 29, 2009

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.
January 30, 2009

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.
August 16, 2019

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.
August 14, 2019

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.
August 1, 2019

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-79-52120-131

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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