Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia

Phase 4

Completed

• Conditions: Torticollis
• Interventions: Biological: botulinum toxin Type A

• Registration Number: NCT01384214
• Lead Sponsor: Allergan

Brief Summary

The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-28
• Last Update Submitted: 2011-06-28
• Study First Posted: 2011-06-29
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Diagnosed with cervical dystonia
• Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection
• In need of additional botulinum toxin Type A injections

Exclusion Criteria

• Surgery or spinal cord stimulation for cervical dystonia
• Previous injections of phenol or alcohol for cervical dystonia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	botulinum toxin Type A	botulinum toxin Type A

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)	Baseline, Week 2

Secondary Outcome Measures

Name	Time	Method
Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score	Week 4
Physician Assessment of Cervical Dystonia Severity	Week 4
Global Assessment of Benefit by Physician	Week 4
Global Assessment of Benefit by Patient	Week 4
Patient Visual Analog Assessment of Pain	Week 4