Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
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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 |
- 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:
|
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 |
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| Contact: Merz Pharmaceuticals, LLC | clinicaltrials@merzusa.com |
Show 45 Study Locations| 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: | April 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Torticollis Dystonia Dystonic Disorders 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 May 21, 2013