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OpenTrials
Completed

NCT Number: NCT00833196

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.

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Key information

Conditions

Idiopathic Cervical Dystonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital, Camperdown, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice

    Time frame: Around 4 weeks post injection

Secondary outcomes

  1. To describe TWSTRS change scores from inclusion (total score & subscales scores)

    Time frame: Baseline, and around 4 weeks and 3 months post injection

  2. To describe tremor change score from inclusion (TSUI scale)

    Time frame: Baseline, and around 4 weeks and 3 months post injection

  3. To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion

    Time frame: Baseline, and around 4 weeks post injection

  4. To describe subject and investigator's CGI scores

    Time frame: Around 4 weeks post injection

  5. To identify prognostic factors for response (Exploratory Objective)

    Time frame: baseline, and around 4 weeks and 3 months post injection

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 30, 2009
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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