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Study was terminated early due to difficulties with patient recruitment
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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® | Experimental | Botulinum toxin type A (BOTOX®) |
|
| Dysport® | Active Comparator | Botulinum toxin type A (Dysport®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin type A | Biological | 200 Units at Visit 1 (Day 1) |
|
| 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 |
| 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). |
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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 |
|---|---|---|---|---|---|---|
| Buenos Aires | Argentina | |||||
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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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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® | Botulinum toxin type A (BOTOX®) |
| BG001 | Dysport® | Botulinum toxin type A (Dysport®) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | 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]. | Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure. | Posted | Median | 95% Confidence Interval | Days | 20 Weeks |
|
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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®) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
The study was terminated early due to difficulties with patient recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | 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 |
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| botulinum toxin type A | Biological | 500 Units at Visit 1 (Day 1) |
|
|
| 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 |
| Parkville |
| Victoria |
| Australia |
| New Delhi | New Delhi | India |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | 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). | Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure. | Posted | Median | Full Range | Scores on a Scale | Week 4 |
|
|
|
| Secondary | 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. | Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure. | Posted | Median | Full Range | Scores on a Scale | Baseline, Week 4 |
|
|
|
| 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: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure. | Posted | Median | Full Range | Units on a Scale | Week 4 |
|
|
|
| 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: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure. | Posted | Median | Full Range | Units on a Scale | Week 4 |
|
|
|
| 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: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. | Posted | Median | Full Range | Units on a Scale | Baseline, Week 4 |
|
|
|
| Secondary | 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'. | Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included. | Posted | Number | Number of Responses | Week 20 |
|
|
|
| Secondary | 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'. | Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included. | Posted | Number | Number of Responses | Week 20 |
|
|
|
| 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: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. | Posted | Median | Full Range | Units on a Scale | Baseline, Week 4 |
|
|
|
| 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: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at the time points are included. | Posted | Number | Number of Responses | Baseline, Week 4 |
|
|
|
| 0 |
| 24 |
| 12 |
| 24 |
| EG001 | Dysport® | Botulinum toxin type A (Dysport®) | 0 | 30 | 12 | 30 |
| Dysphagia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 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 |
| Somewhat Worse |
|
| Same as Previous |
|
| Somewhat Better |
|
| Better |
|
| Much Better |
|
| Somewhat Worse |
|
| Same as Previous |
|
| Somewhat Better |
|
| Better |
|
| Much Better |
|
| Somewhat requires injection at Baseline |
|
| Does not require injection at Baseline |
|
| Absolutely requires injection at Week 4 |
|
| Very much requires injection at Week 4 |
|
| Somewhat requires injection at Week 4 |
|
| Does not require injection at Week 4 |
|