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

Torticollis Clinical Trial

Official title:

Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Cervical Dystonia and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (POSTURe)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655862
• Other study ID #: CMA-BTX-12-001
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: March 28, 2017
• Start date: July 2012
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Dystonia
• Torticollis

Intervention

Biological:
• OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.

Locations

Country	Name	City	State
Canada	Clinique Neuro-Rive Sud	Greenfield Park	Quebec
Canada	Chum-Notre-Dame	Montreal	Quebec
Canada	Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Queen Elizabeth Health Centre: Medical Specialist Clinic	Montreal	Quebec
Canada	Centre Medical Le Mesnil	Quebec
Canada	CHU de Québec, Hôpital de l'Enfant-Jésus	Quebec
Canada	CHU - Sherbrooke	Sherbrooke	Quebec
Canada	Polyclinique Medicale des Ponts	St-Romuald	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score		Baseline, 96 Weeks
Secondary	Patient's Global Impression of Change (PGIC) Using a 7-Point Scale		Baseline, 96 Weeks
Secondary	Work Productivity Assessment Using a 10-Item Questionnaire		96 Weeks
Secondary	Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score		Baseline, 96 Weeks
Secondary	Reasons for Withdrawal of Treatment		96 Weeks