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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01486264
First received: December 2, 2011
Last updated: October 20, 2014
Last verified: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486264

  Hide Study Locations
Locations
United States, Alabama
Merz Investigative Site #001234
Birmingham, Alabama, United States, 35294-0017
United States, California
Merz Investigative Site 001017
Fountain Valley, California, United States, 92708
Merz Investigative Site #001225
Loma Linda, California, United States, 92354-3450
Merz Investigative Site #001219
Los Angeles, California, United States, 90033
United States, Connecticut
Merz Investigative Site # 001276
Manchester, Connecticut, United States, 06040
United States, District of Columbia
Merz Investigative Site #001231
Washington, District of Columbia, United States, 20007
United States, Florida
Merz Investigative Site #001076
Boca Raton, Florida, United States, 33486
Merz Investigative Site #001019
Gainesville, Florida, United States, 32610
Merz Investigative Site #001046
Jacksonville, Florida, United States, 32209
Merz Investigative Site #001075
Melbourne, Florida, United States, 32901
Merz Investigative Site #001217
Port Charlotte, Florida, United States, 33980
Merz Investigative Site #1253
Tampa, Florida, United States, 33613
United States, Georgia
Merz Investigative Site #001055
Atlanta, Georgia, United States, 30329
United States, Illinois
Merz Investigative Site# 01255
Chicago, Illinois, United States, 60611
Merz Investigative Site #001215
Chicago, Illinois, United States, 60612
United States, Iowa
Merz Investigative Site # 01069
Des Moines, Iowa, United States, 50309
United States, Kansas
Merz Investigative Site #001110
Overland Park, Kansas, United States, 66211
United States, Maryland
Merz Investigative Site # 001071
Elkridge, Maryland, United States, 21075
United States, Michigan
Merz Investigative Site # 001018
Detroit, Michigan, United States, 48201-2153
Merz Investigative Site #001030
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Merz Investigative Site # 0001275
Eagan, Minnesota, United States, 55121
United States, Missouri
Merz Investigative Site #001210
St. Louis, Missouri, United States, 63110
Merz Investigative Site #1250
St. Louis, Missouri, United States, 63104
United States, New York
Merz Investigative Site #001221
Albany, New York, United States, 12208
Merz Investigative Site #001233
New York, New York, United States, 10003
Merz Investigative Site #1256
New York, New York, United States, 10029-6574
United States, North Carolina
Merz Investigative Site# 01252
Charlotte, North Carolina, United States, 28207
Merz Investigative Site #001005
Durham, North Carolina, United States, 27705
Merz Investigative Site# 01260
Raleigh, North Carolina, United States, 27607
Merz Investigative Site #001009
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Merz Investigative Site #1265
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Merz Investigative Site #001220
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Merz Investigative Site #1033
Portland, Oregon, United States, 97239
Merz Investigative Site #1251
Portland, Oregon, United States, 97239
United States, Pennsylvania
Merz Investigative Site # 0001271
Hershey, Pennsylvania, United States, 17033
Merz Investigative Site #1249
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Merz Investigative Site #001206
Nashville, Tennessee, United States, 37232-2551
United States, Texas
Merz Investigative Site #001223
Dallas, Texas, United States, 75231
Merz Investigative Site #1074
Dallas, Texas, United States, 75214
Merz Investigative Site # 001216
Houston, Texas, United States, 77030
Merz Investigative Site# 001266
Houston, Texas, United States, 77030
United States, Washington
Merz Investigative Site #001224
Kirkland, Washington, United States, 98034
Merz Investigative Site #1270
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: October 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014