Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex



Status:Completed
Conditions:Neurology, Orthopedic, Women's Studies
Therapuetic Areas:Neurology, Orthopedics / Podiatry, Reproductive
Healthy:No
Age Range:18 - 81
Updated:4/28/2017
Start Date:December 1, 2011
End Date:February 28, 2017

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An Open-Label, Non-Inferiority Study Evaluating the Efficacy and Safety of Two Injection Schedules of Xeomin® (incobotulinumtoxinA) [Short Flex Versus Long Flex] in Subjects With Cervical Dystonia With < 10 Weeks of Benefit From OnabotulinumtoxinA Treatment

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.

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, face, or arms and legs. In focal dystonia, the abnormal movements
involve a single area of the body. A commonly described form of focal dystonia is cervical
dystonia (CD). Botulinum toxin treatment can be offered as a treatment option for the
treatment of CD.

The current practice for botulinum toxin injection treatment is to inject patients every 3
months. However, not all patients receive continuing benefit from botulinum toxin injections
for an entire 3 months. In a recent survey, approximately 45% of patients report that they
would prefer a treatment cycle of less than 10 weeks.This study will compare Xeomin®, a
botulinum toxin treatment, 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 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.

The purpose of this research study is to evaluate the efficacy of the Short Flex dosing of
Xeomin® compared to the Long Flex dosing regimen of Xeomin®, using a standard scale
completed by the doctors and subjects as well as questionnaires that ask subjects to rate
symptoms of CD.

Inclusion Criteria:

- Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia

Exclusion Criteria:

- Current treatment with botulinum toxin of any type for any other indication
(including aesthetic indications) and for any body region during the study.
We found this trial at
43
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Portland, Oregon 97239
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Albany, New York 12208
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Atlanta, Georgia 30329
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Atlanta, GA
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Birmingham, Alabama 35294
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Boca Raton, Florida 33486
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Charlotte, North Carolina 28207
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Chicago, Illinois 60611
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Chicago, Illinois 60611
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Cincinnati, Ohio 45219
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Dallas, Texas 75231
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Dallas, Texas 75231
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Des Moines, Iowa 50309
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Detroit, Michigan 48201
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Durham, North Carolina 27705
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Eagan, Minnesota 55121
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Elkridge, Maryland 21075
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Farmington Hills, Michigan 48334
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Fountain Valley, California 92728
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Gainesville, Florida 32610
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Houston, Texas 77030
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Jacksonville, Florida 32209
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Kirkland, Washington 98034
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Loma Linda, California 92354
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Los Angeles, California 90095
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Manchester, Connecticut 06040
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Melbourne, Florida 32901
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Nashville, Tennessee 37232
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New York, New York 10003
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New York, New York 10003
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New York, New York 10003
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Overland Park, Kansas 66211
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Philadelphia, Pennsylvania 19140
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Port Charlotte, Florida 33980
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Portland, Oregon 97239
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Raleigh, North Carolina 27607
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Saint Louis, Missouri 63104
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Seattle, Washington 98122
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Tampa, Florida 33613
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Tulsa, Oklahoma 74136
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Washington, D.C., District of Columbia 20007
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Winston-Salem, North Carolina 27157
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