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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01655862
First received: July 31, 2012
Last updated: January 12, 2016
Last verified: January 2016

July 31, 2012
January 12, 2016
July 2012
January 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.
 
Active, not recruiting
62
January 2017
January 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   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01655862
CMA-BTX-12-001
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
January 2016

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