Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia
Primary Purpose
Spasmodic Torticollis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
botulinum toxin type A
botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Spasmodic Torticollis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
- Successfully treated previously with botulinum toxin type A
Exclusion Criteria:
- Breast feeding, pregnant or could become pregnant
- Surgery or spinal cord stimulation for cervical dystonia
- Previous injections of phenol, alcohol for cervical dystonia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BOTOX®
Dysport®
Arm Description
botulinum toxin type A (BOTOX®)
botulinum toxin type A (Dysport®)
Outcomes
Primary Outcome Measures
Dysphagia Incidence Over 10 Weeks
Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.
Secondary Outcome Measures
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
The TWSTRS assessments were conducted at each study visit. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.
Physician Assessment of Cervical Dystonia Severity at Week 4
Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever.'
Global Assessment of Benefit by Physician at Week 4
Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'
Global Assessment of Benefit by Patient at Week 4
Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'
Patient Assessment of Need for Retreatment at Week 4
Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer "How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?". The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection' and 'does not require injection'.
Patient Visual Analog Assessment of Pain at Week 4
Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.
Physician Comparison of Benefit to Previous Injections at Week 10
Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
Patient Comparison of Benefit to Previous Injections at Week 10
Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00528541
Brief Title
Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasmodic Torticollis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX®
Arm Type
Active Comparator
Arm Description
botulinum toxin type A (BOTOX®)
Arm Title
Dysport®
Arm Type
Active Comparator
Arm Description
botulinum toxin type A (Dysport®)
Intervention Type
Biological
Intervention Name(s)
botulinum toxin type A
Other Intervention Name(s)
BOTOX®
Intervention Description
200 Units at Visit 1 (Day 1)
Intervention Type
Biological
Intervention Name(s)
botulinum toxin type A
Other Intervention Name(s)
Dysport®
Intervention Description
750 Units at Visit 1 (Day 1)
Primary Outcome Measure Information:
Title
Dysphagia Incidence Over 10 Weeks
Description
Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
Description
The TWSTRS assessments were conducted at each study visit. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.
Time Frame
Baseline, Week 4
Title
Physician Assessment of Cervical Dystonia Severity at Week 4
Description
Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever.'
Time Frame
Baseline, Week 4
Title
Global Assessment of Benefit by Physician at Week 4
Description
Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'
Time Frame
Week 4
Title
Global Assessment of Benefit by Patient at Week 4
Description
Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'
Time Frame
Week 4
Title
Patient Assessment of Need for Retreatment at Week 4
Description
Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer "How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?". The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection' and 'does not require injection'.
Time Frame
Baseline, Week 4
Title
Patient Visual Analog Assessment of Pain at Week 4
Description
Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.
Time Frame
Baseline, Week 4
Title
Physician Comparison of Benefit to Previous Injections at Week 10
Description
Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
Time Frame
Week 10
Title
Patient Comparison of Benefit to Previous Injections at Week 10
Description
Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
Successfully treated previously with botulinum toxin type A
Exclusion Criteria:
Breast feeding, pregnant or could become pregnant
Surgery or spinal cord stimulation for cervical dystonia
Previous injections of phenol, 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
Adelaide
State/Province
South Australia
Country
Australia
City
Zagreb
Country
Croatia
City
Rome
Country
Italy
City
Krakow
Country
Poland
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia
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