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This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® | Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. |
| |
| Xeomin® | Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No treatment (intervention) was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose of Botulinum Toxin Used to Treat Cervical Dystonia | The average dose of botulinum toxin received per patient per year was calculated. | 2 Years |
| Dose of Botulinum Toxin Used to Treat Blepharospasm | The average dose of botulinum toxin received per patient per year was calculated. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period. | 2 Years |
| Botulinum Toxin Inter-injection Interval |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bergen | Norway | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. |
| 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 | Dose of Botulinum Toxin Used to Treat Cervical Dystonia | The average dose of botulinum toxin received per patient per year was calculated. | Participants diagnosed with Cervical Dystonia who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years. | Posted | Mean | 95% Confidence Interval | units per patient per year | 2 Years |
|
2 Years
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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® | Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| D001764 | Blepharospasm |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Injection-interval was the time in weeks between injections of botulinum toxin. |
| 2 Years |
| Wakefield |
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Dose of Botulinum Toxin Used to Treat Blepharospasm | The average dose of botulinum toxin received per patient per year was calculated. | Participants diagnosed with Blepharospasm who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years. | Posted | Mean | 95% Confidence Interval | units per patient per year | 2 Years |
|
|
|
| Secondary | Number of Participants With Adverse Events | An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period. | Safety population included all participants who received at least one dose of botulinum toxin. | Posted | Number | participants | 2 Years |
|
|
|
| Secondary | Botulinum Toxin Inter-injection Interval | Injection-interval was the time in weeks between injections of botulinum toxin. | All participants who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years. | Posted | Mean | Standard Deviation | weeks | 2 Years |
|
|
|
| 0 |
| 48 |
| 7 |
| 48 |
| EG001 | Xeomin® | Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. | 0 | 48 | 4 | 48 |
| Ptosis | Eye disorders | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |