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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: September 23, 2014
Last verified: September 2014

December 2, 2011
September 23, 2014
December 2011
December 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01486264 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cervical Dystonia
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
Experimental: Xeomin®,
Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A.
Intervention: Biological: Xeomin®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
424
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 81 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01486264
MUS 60201 4073 1
No
Merz Pharmaceuticals, LLC
Merz Pharmaceuticals, LLC
Not Provided
Study Director: Micki Seoane Merz Pharmaceuticals, LLC
Merz Pharmaceuticals, LLC
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP