Clinical trial

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

Name

MUS60201_4073_1

Description

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.

Trial arms

Trial start

2012-01-20

Estimated PCD

2016-03-29

Trial end

2016-03-29

Status

Completed

Phase

Early phase I

Treatment

Xeomin®

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

Arms:

Xeomin® Long Flex, Xeomin® Short Flex

Other names:

botulinum toxin, botulinum toxin type A

Size

283

Primary endpoint

Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection

Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 283, 'type': 'ACTUAL'}}

Updated at

2022-10-27

1 organization

1 product

1 indication

Organization

Merz Pharmaceuticals

Product

Xeomin®

Indication

Cervical Dystonia