Overview

This trial is active, not recruiting.

Condition torticollis
Treatment onabotulinumtoxina
Sponsor Allergan
Start date July 2012
End date January 2017
Trial size 62 participants
Trial identifier NCT01655862, CMA-BTX-12-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
onabotulinumtoxina botulinum toxin Type A
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.

Primary Outcomes

Measure
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score
time frame: Baseline, 96 Weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 16 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Allergan.