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To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A Dose 1 | Experimental | Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. |
|
| Botulinum toxin type A Dose 2 | Experimental | Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. |
|
| Placebo (Normal Saline) | Placebo Comparator | Placebo (Normal Saline) intramuscular injections into specified muscles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A Dose 1 | Biological | Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Frequency of Headache Days | Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary. | Baseline, 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Frequency of Severe Headache Days | Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary. |
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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 |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Fullerton Neurology and Headache Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29877131 | Derived | Shah S, Calderon MD, Wu W, Grant J, Rinehart J. Onabotulinumtoxin A (BOTOX(R)) for ProphylaCTIC Treatment of Pediatric Migraine: A Retrospective Longitudinal Analysis. J Child Neurol. 2018 Aug;33(9):580-586. doi: 10.1177/0883073818776142. Epub 2018 Jun 7. |
| Label | URL |
|---|---|
| More Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A 155 U | Botulinum toxin type A, 155 U, intramuscular injections into specified muscles. |
| FG001 | Botulinum Toxin Type A 74 U | Botulinum toxin type A, 74 U, intramuscular injections into specified muscles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Botulinum toxin type A Dose 2 | Biological | Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. |
|
|
| Placebo (Normal Saline) | Drug | Placebo (Normal Saline) intramuscular injections into specified muscles. |
|
| Baseline, 12 Weeks |
| Change From Baseline in the Total Cumulative Hours of Headache on Headache Days | Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days. | Baseline, 12 Weeks |
| Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days | Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days. | Baseline, 12 Weeks |
| Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment | Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population. | 12 Weeks |
| Fullerton |
| California |
| 92835 |
| United States |
| The Research Center of Southern California | Oceanside | California | 92056 | United States |
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States |
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States |
| Associated Neurologists of Southern CT, P.C. | Fairfield | Connecticut | 06824 | United States |
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| NW FL Clinical Research Group, LLC | Gulf Breeze | Florida | 32561 | United States |
| Pediatric Neurology, PA | Orlando | Florida | 32819 | United States |
| The Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Advanced Clinical Research | Meridian | Idaho | 83642 | United States |
| Josephson Wallack Munshower Neurology, P.C. | Indianapolis | Indiana | 46237 | United States |
| CPFCC Neurology Research Department | Overland Park | Kansas | 66212 | United States |
| Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| CORE (Center for Outpatient Research) | Springfield | Missouri | 65804 | United States |
| Renown Institution for Neurosciences | Reno | Nevada | 89502 | United States |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Jill Waldo, CCRC | Pittsburgh | Pennsylvania | 15236 | United States |
| Nashville Neuroscience Group | Nashville | Tennessee | 37203 | United States |
| Texas Association of Pediatric Neurology/Road Runner Research | San Antonio | Texas | 78258 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| FG002 | Placebo (Normal Saline) | Placebo (Normal Saline) intramuscular injections into specified muscles. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A 155 U | Botulinum toxin type A, 155 U, intramuscular injections into specified muscles. |
| BG001 | Botulinum Toxin Type A 74 U | Botulinum toxin type A, 74 U, intramuscular injections into specified muscles. |
| BG002 | Placebo (Normal Saline) | Placebo (Normal Saline) intramuscular injections into specified muscles. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 |
| |||||||||||||||
| Sex/Gender, Customized | Number | 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 | Change From Baseline in the Frequency of Headache Days | Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary. | Intent-to-Treat (ITT) Population: All randomized subjects. | Posted | Mean | Standard Deviation | Headache days | Baseline, 12 Weeks |
|
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| Secondary | Change From Baseline in the Frequency of Severe Headache Days | Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary. | Intent-to-Treat (ITT) Population: All randomized subjects. | Posted | Mean | Standard Deviation | Severe Headache Days | Baseline, 12 Weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Total Cumulative Hours of Headache on Headache Days | Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days. | Intent-to-Treat (ITT) Population: All randomized subjects. | Posted | Mean | Standard Deviation | Cumulative hours of headache | Baseline, 12 Weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days | Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days. | Intent-to-Treat (ITT) Population: All randomized subjects. | Posted | Number | Percentage of participants | Baseline, 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment | Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population. | Intent-to-Treat (ITT) Population: All randomized subjects. | Posted | Number | Percentage of participants | 12 Weeks |
|
|
Up to Week 12
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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 155 U | Botulinum toxin type A, 155 U, intramuscular injections into specified muscles. | 1 | 43 | 8 | 43 | ||
| EG001 | Botulinum Toxin Type A 74 U | Botulinum toxin type A, 74 U, intramuscular injections into specified muscles. | 2 | 43 | 14 | 43 | ||
| EG002 | Placebo (Normal Saline) | Placebo (Normal Saline) intramuscular injections into specified muscles. | 0 | 37 | 8 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA, version 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA, version 19.0 | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA, version 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA, version 19.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA, version 19.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Participants |
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