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

NCT01486264 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2022-10-27

Study results available
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Summary

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.

Conditions

  • Cervical Dystonia

Interventions

BIOLOGICAL

Xeomin®

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

Sponsors & Collaborators

  • Merz North America, Inc.

    collaborator INDUSTRY

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Kulagowski, MD · Merz North America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-20
Primary Completion
2016-03-29
Completion
2016-03-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486264 on ClinicalTrials.gov