Overview

This trial is active, not recruiting.

Condition cervical dystonia
Treatment xeomin®
Phase phase 4
Sponsor Merz Pharmaceuticals, LLC
Start date December 2011
End date March 2016
Trial size 286 participants
Trial identifier NCT01486264, MUS 60201 4073 1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
short flex dosing of Xeomin. It is a botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A.
xeomin® botulinum toxin
Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A
(Active Comparator)
long flex dosing of Xeomin. It is a botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A.
xeomin® botulinum toxin
Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 81 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Merz Pharmaceuticals, LLC.