A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA

Completed

• Conditions: Torticollis
• Interventions: Biological: OnabotulinumtoxinA

• Registration Number: NCT01655862
• Lead Sponsor: Allergan

Brief Summary

This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician

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Exclusion Criteria

• Participation in a clinical trial for any botulinum toxin indication
• Planning elective surgery during the observational study period
• Treatment with any botulinum toxin product for cervical dystonia (dystonie)
• Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OnabotulinumtoxinA	OnabotulinumtoxinA	OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score	Baseline, 96 Weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score	Baseline, 96 Weeks
Work Productivity Assessment Using a 10-Item Questionnaire	96 Weeks
Patient's Global Impression of Change (PGIC) Using a 7-Point Scale	Baseline, 96 Weeks
Reasons for Withdrawal of Treatment	96 Weeks

Trial Locations

Locations (8)

Centre Medical Le Mesnil; 🇨🇦 Quebec, Canada

CHU de Québec, Hôpital de l'Enfant-Jésus; 🇨🇦 Quebec, Canada

Clinique Neuro-Rive Sud; 🇨🇦 Greenfield Park, Quebec, Canada

CHU - Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

Queen Elizabeth Health Centre: Medical Specialist Clinic; 🇨🇦 Montreal, Quebec, Canada

Polyclinique Medicale des Ponts; 🇨🇦 St-Romuald, Quebec, Canada

Chum-Notre-Dame; 🇨🇦 Montreal, Quebec, Canada