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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01655862
First received: July 31, 2012
Last updated: June 13, 2014
Last verified: June 2014

July 31, 2012
June 13, 2014
July 2012
October 2017   (final data collection date for primary outcome measure)
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score [ Time Frame: Baseline, 96 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01655862 on ClinicalTrials.gov Archive Site
  • Patient's Global Impression of Change (PGIC) Using a 7-Point Scale [ Time Frame: Baseline, 96 Weeks ] [ Designated as safety issue: No ]
  • Work Productivity Assessment Using a 10-Item Questionnaire [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score [ Time Frame: Baseline, 96 Weeks ] [ Designated as safety issue: No ]
  • Reasons for Withdrawal of Treatment [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA
Not Provided

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with Cervical Dystonia (Dystonie)

Torticollis
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Other Names:
  • botulinum toxin Type A
  • BOTOX®
OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Intervention: Biological: OnabotulinumtoxinA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
November 2017
October 2017   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Allergan Inc. clinicaltrials@allergan.com
Canada
 
NCT01655862
CMA-BTX-12-001
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP