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Recently published BOTOX efficacy data and study design deficits.
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purposes of this study are to assess whether subjects treated with BOTOX will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin Type A | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | 100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. | 190 days |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. | 190 days | |
| To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache. |
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Inclusion Criteria:
Exclusion Criteria:
Additional eligibility will be discussed at point of contact
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Taylor, MD | Park Nicollet Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Park Nicollet Health Services | Minneapolis | Minnesota | 55426 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. | Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data | Posted | 190 days |
|
|
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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 | Botulinum Toxin Type A |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat | Infections and infestations | Systematic Assessment |
This study was terminated and PI left organization. No results available to report
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Park Nicollet Institute | Park Nicollet Institute | 952-993-3123 |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 190 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Secondary | To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. | Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data | Posted | 190 days |
|
|
| Secondary | To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache. | Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data | Posted | 190 days |
|
|
| 0 |
| 35 |
| 6 |
| 35 |
| Soreness, posterior neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| 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 |