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

NCT ID: NCT01486264

Last Updated: 2022-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-20

Study Completion Date

2016-03-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervical Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Xeomin® Short Flex

short flex dosing of Xeomin. It is a botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A.

Group Type ACTIVE_COMPARATOR

Xeomin®

Intervention Type BIOLOGICAL

Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A

Xeomin® Long Flex

long flex dosing of Xeomin. It is a botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A.

Group Type ACTIVE_COMPARATOR

Xeomin®

Intervention Type BIOLOGICAL

Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A

Interventions

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Xeomin®

Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A

Intervention Type BIOLOGICAL

Other Intervention Names

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botulinum toxin botulinum toxin type A

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz North America, Inc.

INDUSTRY

Sponsor Role collaborator

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Kulagowski, MD

Role: STUDY_DIRECTOR

Merz North America, Inc.

Locations

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Merz Investigative Site #001234

Birmingham, Alabama, United States

Site Status

Merz Investigative Site 001017

Fountain Valley, California, United States

Site Status

Merz Investigative Site #001225

Loma Linda, California, United States

Site Status

Merz Investigative Site #001219

Los Angeles, California, United States

Site Status

Merz Investigative Site # 001276

Manchester, Connecticut, United States

Site Status

Merz Investigative Site #001231

Washington D.C., District of Columbia, United States

Site Status

Merz Investigative Site #001076

Boca Raton, Florida, United States

Site Status

Merz Investigative Site #001019

Gainesville, Florida, United States

Site Status

Merz Investigative Site #001046

Jacksonville, Florida, United States

Site Status

Merz Investigative Site #001075

Melbourne, Florida, United States

Site Status

Merz Investigative Site #001217

Port Charlotte, Florida, United States

Site Status

Merz Investigative Site #1253

Tampa, Florida, United States

Site Status

Merz Investigative Site #001055

Atlanta, Georgia, United States

Site Status

Merz Investigative Site# 01255

Chicago, Illinois, United States

Site Status

Merz Investigative Site #001215

Chicago, Illinois, United States

Site Status

Merz Investigative Site # 01069

Des Moines, Iowa, United States

Site Status

Merz Investigative Site #001110

Overland Park, Kansas, United States

Site Status

Merz Investigative Site # 001071

Elkridge, Maryland, United States

Site Status

Merz Investigative Site # 001018

Detroit, Michigan, United States

Site Status

Merz Investigative Site #001030

Farmington Hills, Michigan, United States

Site Status

Merz Investigative Site # 0001275

Eagan, Minnesota, United States

Site Status

Merz Investigative Site #1250

St Louis, Missouri, United States

Site Status

Merz Investigative Site #001210

St Louis, Missouri, United States

Site Status

Merz Investigative Site #001221

Albany, New York, United States

Site Status

Merz Investigative Site #001233

New York, New York, United States

Site Status

Merz Investigative Site #1256

New York, New York, United States

Site Status

Merz Investigative Site# 01252

Charlotte, North Carolina, United States

Site Status

Merz Investigative Site #001005

Durham, North Carolina, United States

Site Status

Merz Investigative Site# 01260

Raleigh, North Carolina, United States

Site Status

Merz Investigative Site #001009

Winston-Salem, North Carolina, United States

Site Status

Merz Investigative Site #1265

Cincinnati, Ohio, United States

Site Status

Merz Investigative Site #001220

Tulsa, Oklahoma, United States

Site Status

Merz Investigative Site #1033

Portland, Oregon, United States

Site Status

Merz Investigative Site #1251

Portland, Oregon, United States

Site Status

Merz Investigative Site # 0001271

Hershey, Pennsylvania, United States

Site Status

Merz Investigative Site #1249

Philadelphia, Pennsylvania, United States

Site Status

Merz Investigative Site #001206

Nashville, Tennessee, United States

Site Status

Merz Investigative Site #1074

Dallas, Texas, United States

Site Status

Merz Investigative Site #001223

Dallas, Texas, United States

Site Status

Merz Investigative Site # 001216

Houston, Texas, United States

Site Status

Merz Investigative Site# 001266

Houston, Texas, United States

Site Status

Merz Investigative Site #001224

Kirkland, Washington, United States

Site Status

Merz Investigative Site #1270

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Comella C, Hauser RA, Isaacson SH, Truong D, Oguh O, Hui J, Molho ES, Brodsky M, Furr-Stimming E, Comes G, Hast MA, Charles D. Efficacy and safety of two incobotulinumtoxinA injection intervals in cervical dystonia patients with inadequate benefit from standard injection intervals of botulinum toxin: Phase 4, open-label, randomized, noninferiority study. Clin Park Relat Disord. 2022 Mar 14;6:100142. doi: 10.1016/j.prdoa.2022.100142. eCollection 2022.

Reference Type RESULT
PMID: 35330880 (View on PubMed)

Other Identifiers

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MUS60201_4073_1

Identifier Type: -

Identifier Source: org_study_id

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