Trial record 1 of 1 for:    MUS 60201 4073 1
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Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex

This study is currently recruiting participants.
Verified March 2014 by Merz Pharmaceuticals, LLC
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01486264
First received: December 2, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cervical Dystonia
Biological: Xeomin®
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Efficacy of the Short Flex dosing of Xeomin® compared to the Long Flex dosing regimen of Xeomin®, [ Time Frame: Four weeks post the 8th injection ] [ Designated as safety issue: Yes ]
    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 your doctors and you as well as questionnaires that ask subjects to rate symptoms of CD.


Estimated Enrollment: 424
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xeomin®,
Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A.
Biological: Xeomin®
Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A
Other Names:
  • botulinum toxin
  • botulinum toxin type A

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.

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486264

Contacts
Contact: Merz Pharmaceuticals, LLC clinicaltrials@merzusa.com

  Hide Study Locations
Locations
United States, Alabama
Merz Investigative Site #001234 Recruiting
Birmingham, Alabama, United States, 35294-0017
United States, California
D. Truong, MD Recruiting
Fountain Valley, California, United States, 92708
Principal Investigator: D. Truong, MD         
Merz Investigative Site #001225 Recruiting
Loma Linda, California, United States, 92354-3450
Merz Investigative Site #001219 Recruiting
Los Angeles, California, United States, 90033
United States, District of Columbia
Merz Investigative Site #001231 Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Merz Investigative Site #001076 Recruiting
Boca Raton, Florida, United States, 33486
Merz Investigative Site #001019 Recruiting
Gainesville, Florida, United States, 32610
Merz Investigative Site #001046 Recruiting
Jacksonville, Florida, United States, 32209
Merz Investigative Site #001075 Recruiting
Melbourne, Florida, United States, 32901
Merz Investigative Site #001217 Recruiting
Port Charlotte, Florida, United States, 33980
Merz Investigative Site #1253 Recruiting
Tampa, Florida, United States, 33613
Merz Investigative Site # 0001268 Recruiting
Weston, Florida, United States, 33331
United States, Georgia
Merz Investigative Site #001055 Recruiting
Atlanta, Georgia, United States, 30329
Merz Investigative Site # 1037 Recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Merz Investigative Site #001215 Recruiting
Chicago, Illinois, United States, 60612
Merz Investigative Site# 01255 Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Merz Investigative Site #01263 Recruiting
Fort Wayne, Indiana, United States, 46804
United States, Iowa
Merz Investigative Site # 01069 Recruiting
Des Moines, Iowa, United States, 50309
United States, Kansas
Merz Investigative Site #001110 Recruiting
Overland Park, Kansas, United States, 66211
United States, Maryland
Merz Investigative Site # 001071 Recruiting
Elkridge, Maryland, United States, 21075
United States, Michigan
Merz Investigative Site # 001018 Recruiting
Detroit, Michigan, United States, 48201-2153
Merz Investigative Site #001030 Recruiting
Farmington Hills, Michigan, United States, 48334
Merz Investigative Site# 001259 Recruiting
Roseville, Michigan, United States, 48066
United States, Minnesota
Merz Investigative Site # 0001275 Recruiting
Eagan, Minnesota, United States, 55121
United States, Missouri
Merz Investigative Site #001210 Recruiting
St. Louis, Missouri, United States, 63110
Merz Investigative Site #1250 Recruiting
St. Louis, Missouri, United States, 63104
United States, New Jersey
Merz Investigative Site # 0001267 Recruiting
Flemington, New Jersey, United States, 08822
United States, New York
Merz Investigative Site #001221 Recruiting
Albany, New York, United States, 12208
Merz Investigative Site #001233 Recruiting
New York, New York, United States, 10003
Merz Investigative #001218 Withdrawn
New York, New York, United States, 10032
Merz Investigative Site #1256 Recruiting
New York, New York, United States, 10029-6574
United States, North Carolina
Merz Investigative Site# 01252 Recruiting
Charlotte, North Carolina, United States, 28207
Merz Investigative Site #001005 Recruiting
Durham, North Carolina, United States, 27705
Merz Investigative Site# 01260 Recruiting
Raleigh, North Carolina, United States, 27607
Merz Investigative Site #001009 Recruiting
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Merz Investigative Site #1265 Recruiting
Cincinnati, Ohio, United States, 45219
Merz Investigative Site #001232 Withdrawn
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Merz Investigative Site #001220 Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Merz Investigative Site #1033 Recruiting
Portland, Oregon, United States, 97239
Merz Investigative Site #1251 Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Merz Investigative Site # 0001271 Recruiting
Hershey, Pennsylvania, United States, 17033
Merz Investigative Site #1249 Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Merz Investigative Site #001228 Withdrawn
Memphis, Tennessee, United States, 38163
Merz Investigative Site #001206 Recruiting
Nashville, Tennessee, United States, 37232-2551
United States, Texas
Merz Investigative Site #001223 Recruiting
Dallas, Texas, United States, 75231
Merz Investigative Site #1074 Recruiting
Dallas, Texas, United States, 75214
Merz Investigative Site # 001216 Recruiting
Houston, Texas, United States, 77030
Merz Investigative Site# 001266 Recruiting
Houston, Texas, United States, 77030
United States, Washington
Merz Investigative Site #001224 Recruiting
Kirkland, Washington, United States, 98034
Merz Investigative Site #1270 Recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Study Director: Micki Seoane Merz Pharmaceuticals, LLC
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01486264     History of Changes
Other Study ID Numbers: MUS 60201 4073 1
Study First Received: December 2, 2011
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014