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

Condition(s) targeted: Cervical Dystonia

Intervention: Xeomin® (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: Merz Pharmaceuticals, LLC

Official(s) and/or principal investigator(s):
Micki Seoane, Study Director, Affiliation: Merz Pharmaceuticals, LLC

Overall contact:
Micki Seoane, Phone: 336-217-2345, Email: mseoane@merzusa.com

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.

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Efficacy of the Short Flex dosing of Xeomin® compared to the Long Flex dosing regimen of Xeomin®,

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, 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.

Minimum age: 18 Years. Maximum age: 81 Years. Gender(s): Both.

Criteria:

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.

Micki Seoane, Phone: 336-217-2345, Email: mseoane@merzusa.com

Merz Investigative Site #001234, Birmingham, Alabama 35294-0017, United States; Recruiting

D. Truong, MD, Fountain Valley, California 92708, United States; Recruiting
D. Truong, MD, Principal Investigator

Merz Investigative Site #001225, Loma Linda, California 92354-3450, United States; Recruiting

Merz Investigative Site #001219, Los Angeles, California 90033, United States; Recruiting

Merz Investigative Site #001231, Washington, District of Columbia 20007, United States; Recruiting

Merz Investigative Site #001076, Boca Raton, Florida 33486, United States; Recruiting

Merz Investigative Site #001019, Gainesville, Florida 32610, United States; Recruiting

Merz Investigative Site #001046, Jacksonville, Florida 32209, United States; Recruiting

Merz Investigative Site #001075, Melbourne, Florida 32901, United States; Recruiting

Merz Investigative Site #001217, Port Charles, Florida 33980, United States; Recruiting

Merz Investigative Site #1253, Tampa, Florida 33613, United States; Recruiting

Merz Investigative Site #001055, Atlanta, Georgia 30329, United States; Recruiting

Merz Investigative Site # 1037, Augusta, Georgia 30912, United States; Recruiting

Merz Investigative Site #001215, Chicago, Illinois 60612, United States; Recruiting

Merz Investigative Site# 01255, Chicago, Illinois 60611, United States; Recruiting

Merz Investigative Site #01263, Fort Wayne, Indiana 46804, United States; Recruiting

Merz Investigative Site # 01069, Des Moines, Iowa 50309, United States; Recruiting

Merz Investigative Site #001110, Overland Park, Kansas 66211, United States; Recruiting

Merz Investigative Site # 001071, Elkridge, Maryland 21075, United States; Recruiting

Merz Investigative Site # 001018, Detroit, Michigan 48201-2153, United States; Recruiting

Merz Investigative Site #001030, Farmington Hills, Michigan 48334, United States; Recruiting

Merz Investigative Site# 001259, Roseville, Michigan 48066, United States; Recruiting

Merz Investigative Site #001210, St. Louis, Missouri 63110, United States; Recruiting

Merz Investigator #01210, St. Louis, Missouri 63110, United States; Recruiting

Merz Investigative Site #001221, Albany, New York 12208, United States; Recruiting

Merz Investigative Site #1256, New York, New York 10029-6574, United States; Recruiting

Merz Investigative #001218, New York, New York 10032, United States; Recruiting

Merz Investigative Site #001233, New York, New York 10003, United States; Recruiting

Merz Investigative Site# 01252, Charlotte, North Carolina 28207, United States; Recruiting

Merz Investigative Site #001005, Durham, North Carolina 27705, United States; Recruiting

Merz Investigative Site# 01260, Raleigh, North Carolina 27607, United States; Recruiting

Merz Investigative Site #001009, Winston Salem, North Carolina 27157, United States; Recruiting

Merz Investigative Site #001232, Cleveland, Ohio 44195, United States; Recruiting

Merz Investigative Site #001220, Tulsa, Oklahoma 74136, United States; Recruiting

Merz Investigative Site #1033, Portland, Oregon 97239, United States; Recruiting

Merz Investigative Site #001228, Memphis, Tennessee 38163, United States; Recruiting

Merz Investigative Site #001206, Nashville, Tennessee 37232-2551, United States; Recruiting

Merz Investigative Site #001223, Dallas, Texas 75231, United States; Recruiting

Merz Investigative Site #1074, Dallas, Texas 75214, United States; Recruiting

Merz Investigative Site # 001216, Houston, Texas 77030, United States; Recruiting

Merz Investigative Site #001224, Kirkland, Washington 98034, United States; Recruiting

Starting date: December 2011
Last updated: February 5, 2013