Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
Completed · Phase 4
Conditions studied: Cervical Dystonia
In brief
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 treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.
Key facts
- Study ID
- NCT01486264
- Run by
- Merz Pharmaceuticals GmbH
- People needed
- 283
- Starts
- 2012-01-20
- Expected to finish
- 2016-03-29
- Last updated by the study team
- 2022-10-27
Who can join
Age: 18 and older, up to 81. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia
You may not qualify if…
- Current treatment with botulinum toxin of any type for any other indication (including aesthetic indications) and for any body region during the study.
Where it is running
- Merz Investigative Site #001234 — Birmingham, Alabama, United States
- Merz Investigative Site 001017 — Fountain Valley, California, United States
- Merz Investigative Site #001225 — Loma Linda, California, United States
- Merz Investigative Site #001219 — Los Angeles, California, United States
- Merz Investigative Site # 001276 — Manchester, Connecticut, United States
- Merz Investigative Site #001231 — Washington D.C., District of Columbia, United States
- Merz Investigative Site #001076 — Boca Raton, Florida, United States
- Merz Investigative Site #001019 — Gainesville, Florida, United States
- Merz Investigative Site #001046 — Jacksonville, Florida, United States
- Merz Investigative Site #001075 — Melbourne, Florida, United States
- Merz Investigative Site #001217 — Port Charlotte, Florida, United States
- Merz Investigative Site #1253 — Tampa, Florida, United States
- Merz Investigative Site #001055 — Atlanta, Georgia, United States
- Merz Investigative Site# 01255 — Chicago, Illinois, United States
- Merz Investigative Site #001215 — Chicago, Illinois, United States
- Merz Investigative Site # 01069 — Des Moines, Iowa, United States
- Merz Investigative Site #001110 — Overland Park, Kansas, United States
- Merz Investigative Site # 001071 — Elkridge, Maryland, United States
- Merz Investigative Site # 001018 — Detroit, Michigan, United States
- Merz Investigative Site #001030 — Farmington Hills, Michigan, United States
- Merz Investigative Site # 0001275 — Eagan, Minnesota, United States
- Merz Investigative Site #1250 — St Louis, Missouri, United States
- Merz Investigative Site #001210 — St Louis, Missouri, United States
- Merz Investigative Site #001221 — Albany, New York, United States
- Merz Investigative Site #001233 — New York, New York, United States
Full record on ClinicalTrials.gov
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