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

Ipsen36 sites in 9 countries404 target enrollmentFebruary 2009

ConditionsIdiopathic Cervical Dystonia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Idiopathic Cervical Dystonia
Sponsor: Ipsen
Enrollment: 404
Locations: 36
Primary Endpoint: Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

April 2010

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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