Back to resultsEffect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia
Primary Purpose
Torticollis
Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
botulinum toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Torticollis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
botulinum toxin Type A
Outcomes
Primary Outcome Measures
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)
Secondary Outcome Measures
Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score
Physician Assessment of Cervical Dystonia Severity
Global Assessment of Benefit by Physician
Global Assessment of Benefit by Patient
Patient Visual Analog Assessment of Pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01384214
Brief Title
Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia
Official Title
Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Torticollis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
botulinum toxin Type A
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
Dysport®
Intervention Description
750 U at Visit 1
Primary Outcome Measure Information:
Title
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)
Time Frame
Baseline, Week 2
Secondary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score
Time Frame
Week 4
Title
Physician Assessment of Cervical Dystonia Severity
Time Frame
Week 4
Title
Global Assessment of Benefit by Physician
Time Frame
Week 4
Title
Global Assessment of Benefit by Patient
Time Frame
Week 4
Title
Patient Visual Analog Assessment of Pain
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Zagreb
Country
Croatia
12. IPD Sharing Statement
Learn more about this trial
Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia
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