- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00432341
Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia
November 14, 2011 updated by: Allergan
The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BOTOX®
Botulinum toxin type A (BOTOX®)
|
200 Units at Visit 1 (Day 1)
Other Names:
500 Units at Visit 1 (Day 1)
Other Names:
|
Active Comparator: Dysport®
Botulinum toxin type A (Dysport®)
|
200 Units at Visit 1 (Day 1)
Other Names:
500 Units at Visit 1 (Day 1)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Treatment Benefit
Time Frame: 20 Weeks
|
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].
|
20 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Visual Analog Assessment of Pain at Week 4
Time Frame: Baseline, 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'.
|
Baseline, Week 4
|
Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4
Time Frame: 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).
|
Week 4
|
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
Time Frame: Baseline, 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.
|
Baseline, Week 4
|
Global Assessment of Benefit by Patient at Week 4
Time Frame: 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)'.
|
Week 4
|
Global Assessment of Benefit by Physician at Week 4
Time Frame: 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)'.
|
Week 4
|
Physician Assessment of Cervical Dystonia Severity at Week 4
Time Frame: Baseline, 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'
|
Baseline, Week 4
|
Physician Comparison of Benefit to Previous Injections at Week 20
Time Frame: 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'.
|
Week 20
|
Patient Comparison of Benefit to Previous Injections at Week 20
Time Frame: 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'.
|
Week 20
|
Patient Assessment of Need for Retreatment at Week 4
Time Frame: Baseline, 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'.
|
Baseline, Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
February 5, 2007
First Submitted That Met QC Criteria
February 5, 2007
First Posted (Estimate)
February 7, 2007
Study Record Updates
Last Update Posted (Estimate)
December 16, 2011
Last Update Submitted That Met QC Criteria
November 14, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Dyskinesias
- Dystonia
- Torticollis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- MedAff-BTX-0615
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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