Status:
COMPLETED
Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
Lead Sponsor:
Merz Pharmaceuticals GmbH
Collaborating Sponsors:
Merz North America, Inc.
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18-81 years
Phase:
PHASE4
Brief Summary
This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to tre...
Detailed Description
Dystonia is a movement disorder which is characterized by sustained, involuntary muscle contractions which frequently causes twisting and repetitive movements or abnormal postures of the trunk, neck, ...
Eligibility Criteria
Inclusion
- Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia
Exclusion
- Current treatment with botulinum toxin of any type for any other indication (including aesthetic indications) and for any body region during the study.
Key Trial Info
Start Date :
January 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2016
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT01486264
Start Date
January 20 2012
End Date
March 29 2016
Last Update
October 27 2022
Active Locations (43)
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1
Merz Investigative Site #001234
Birmingham, Alabama, United States, 35294-0017
2
Merz Investigative Site 001017
Fountain Valley, California, United States, 92708
3
Merz Investigative Site #001225
Loma Linda, California, United States, 92354-3450
4
Merz Investigative Site #001219
Los Angeles, California, United States, 90033