A Prospective, Observational Study of Patients With Cervical Dystonia Treated With OnabotulinumtoxinA
This study is currently recruiting participants.
Verified July 2012 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01655862
First received: July 31, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
Tracking Information | |||||
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First Received Date ICMJE | July 31, 2012 | ||||
Last Updated Date | July 31, 2012 | ||||
Start Date ICMJE | July 2012 | ||||
Estimated Primary Completion Date | October 2017 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score [ Time Frame: Baseline, 96 Weeks ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Prospective, Observational Study of Patients With Cervical Dystonia Treated With OnabotulinumtoxinA | ||||
Official Title ICMJE | |||||
Brief Summary | This is an observational study to assess health-related quality of life in patients with cervical dystonia treated with OnabotulinumtoxinA per routine clinical practice. |
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Detailed Description | |||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients with Cervical Dystonia |
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Condition ICMJE | Torticollis | ||||
Intervention ICMJE | Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice
Other Names:
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Study Group/Cohort (s) | OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice
Intervention: Biological: OnabotulinumtoxinA |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 250 | ||||
Estimated Completion Date | November 2017 | ||||
Estimated Primary Completion Date | October 2017 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 16 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01655862 | ||||
Other Study ID Numbers ICMJE | CMA-BTX-12-001 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Allergan | ||||
Study Sponsor ICMJE | Allergan | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Allergan | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |