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

Completed

• Conditions: Idiopathic Cervical Dystonia

• Registration Number: NCT00833196
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Study Start: 2009-02
• Primary Completion: 2010-02
• Study Completion: 2010-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice	Around 4 weeks post injection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (36)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, Australia

St Vincent's Hospital; 🇦🇺 Fitzroy, Australia

Austin Hospital; 🇦🇺 Heidelberg, Australia

Westmead Hospital; 🇦🇺 Penrith, Australia

Alfred Hospital; 🇦🇺 Prahran, Australia

AZ Sint Jan Brugge; 🇧🇪 Brugge, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen; 🇧🇪 Liege, Belgium

AZ Sint Augustinus Wilrijk; 🇧🇪 Wilrijk, Belgium

Fakultní nemocnice U Sv.Anny; 🇨🇿 Brno, Czechia

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