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Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia

Primary Purpose

Spasmodic Torticollis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
botulinum toxin type A
botulinum toxin type A
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasmodic Torticollis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Experimental

Active Comparator

Arm Label

BOTOX®

Dysport®

Arm Description

Botulinum toxin type A (BOTOX®)

Botulinum toxin type A (Dysport®)

Outcomes

Primary Outcome Measures

Duration of Treatment Benefit
Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].

Secondary Outcome Measures

Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4
The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms). The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score 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.
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)'.
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)'.
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'
Physician Comparison of Benefit to Previous Injections at Week 20
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 20
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'.
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'.
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'.

Full Information

First Posted
February 5, 2007
Last Updated
November 14, 2011
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00432341
Brief Title
Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated early due to difficulties with patient recruitment
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 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
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BOTOX®
Arm Type
Experimental
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
500 Units at Visit 1 (Day 1)
Primary Outcome Measure Information:
Title
Duration of Treatment Benefit
Description
Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].
Time Frame
20 Weeks
Secondary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4
Description
The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms). The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).
Time Frame
Week 4
Title
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
Description
The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score 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
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
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
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
Physician Comparison of Benefit to Previous Injections at Week 20
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 20
Title
Patient Comparison of Benefit to Previous Injections at Week 20
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 20
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
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

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/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
Buenos Aires
Country
Argentina
City
Parkville
State/Province
Victoria
Country
Australia
City
New Delhi
Country
India

12. IPD Sharing Statement

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Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia

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