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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® | Active Comparator | botulinum toxin type A (BOTOX®) |
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| Dysport® | Active Comparator | botulinum toxin type A (Dysport®) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin type A | Biological | 200 Units at Visit 1 (Day 1) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | South Australia | Australia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX® | botulinum toxin type A (BOTOX®) |
| FG001 | Dysport® | botulinum toxin type A (Dysport®) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| botulinum toxin type A | Biological | 750 Units at Visit 1 (Day 1) |
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| Baseline, 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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'. | Week 10 |
| 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'. | Week 10 |
| Zagreb |
| Croatia |
| Rome | Italy |
| Krakow | Poland |
| Istanbul | Turkey (Türkiye) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® | botulinum toxin type A (BOTOX®) |
| BG001 | Dysport® | botulinum toxin type A (Dysport®) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. | Posted | Number | Number of patients | 10 weeks |
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| Secondary | 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. | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. | Posted | Median | Full Range | Scores on a Scale | Baseline, Week 4 |
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| Secondary | 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.' | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. | Posted | Median | Full Range | Units on a Scale | Baseline, Week 4 |
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| Secondary | 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).' | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. | Posted | Median | Full Range | Units on a Scale | Week 4 |
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| Secondary | 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).' | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. | Posted | Median | Full Range | Units on a Scale | Week 4 |
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| Secondary | 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'. | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at the time points are included. | Posted | Number | Number of Responses | Baseline, Week 4 |
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| Secondary | 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'. | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. | Posted | Median | Full Range | Units on a Scale | Baseline, Week 4 |
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| Secondary | 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'. | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this time point are included. | Posted | Number | Number of Responses | Week 10 |
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| Secondary | 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'. | Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this timepoint are included. | Posted | Number | Number of Responses | Week 10 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BOTOX® | botulinum toxin type A (BOTOX®) | 0 | 75 | 5 | 75 | ||
| EG001 | Dysport® | botulinum toxin type A (Dysport®) | 0 | 70 | 4 | 70 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release for a period that is not less than 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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