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

Conditions

• Cervical Dystonia

Eligibility Criteria

Sex

ALL

Age

18 Years - 81 Years

Healthy Volunteers

Not accepted

Interventions

• Xeomin® — BIOLOGICAL
  Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A

Study Details

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.

Key Dates

Start date

Jan 20, 2012

Status verified

Apr 2017

Primary completion

Mar 29, 2016

Completion

Mar 29, 2016

Study Design

Enrollment

283 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Active Comparator: 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.

Primary Outcome Measure

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

Locations (43)

Find similar trials in Birmingham, AL

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