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

Study Overview
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Brief Summary
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The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck

Conditions
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Spasmodic Torticollis

Intervention / Treatment
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* Biological: botulinum toxin type A
* Biological: botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX®<br>Botulinum toxin type A (BOTOX®) | Biological: botulinum toxin type A<br>* 200 Units at Visit 1 (Day 1)<br>* Other names: BOTOX®;|
| Active Comparator: Dysport®<br>Botulinum toxin type A (Dysport®) | Biological: botulinum toxin type A<br>* 500 Units at Visit 1 (Day 1)<br>* Other names: Dysport®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. | 20 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Week 4 | 
| 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. | Baseline, Week 4 | 
| 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)'. | Week 4 | 
| 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)'. | Week 4 | 
| 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' | Baseline, Week 4 | 
| 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'. | Week 20 | 
| 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'. | Week 20 | 
| 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'. | Baseline, Week 4 | 
| 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'. | Baseline, Week 4 |