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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2016 |
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Main ID: |
NCT02245958 |
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Date of registration:
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18/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm
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Scientific title:
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Date of first enrolment:
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August 2015 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02245958 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Phase:
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Countries of recruitment
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Mexico
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United Kingdom
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at
least 2 years
- Treatment with Xeomin® and BOTOX® for at least 2 years each.
Exclusion Criteria:
- Having a neuromuscular junction transmission disorder or taking any medications that
could affect neuromuscular junction transmission
- Previous surgical procedure involving bone or muscle for the management of cervical
dystonia or blepharospasm.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cervical Dystonia
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Blepharospasm
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Intervention(s)
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Other: No Intervention
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Primary Outcome(s)
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Dose of Botulinum Toxin Used to Treat Blepharospasm
[Time Frame: 4 Years]
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Dose of Botulinum Toxin Used to Treat Cervical Dystonia
[Time Frame: 4 Years]
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Secondary Outcome(s)
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Number of Participants with Adverse Events
[Time Frame: 4 Years]
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Botulinum Toxin Inter-injection Intervals
[Time Frame: 4 Years]
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Annual Botulinum Toxin Dose per Patient
[Time Frame: 4 Years]
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Secondary ID(s)
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GMA-US-NEU-0271
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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