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| ID | Type | Description | Link |
|---|---|---|---|
| UCIANES09 | Other Identifier | University of California, Irvine |
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| Name | Class |
|---|---|
| American Society of Regional Anesthesia | OTHER |
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The purpose of the research is to examine the outcomes of pediatric patients receiving Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric patients, specifically in the treatment of migraines.
Medical Literature approximates one in three children will experience chronic headaches in their lifetime, which increases as children reach adolescence. Migraines make up nearly 60% of all visits to a pediatric headache specialist. Studies have demonstrated the negative impact of having childhood migraine on overall quality of life is similar to pediatric cancer, heart disease and rheumatic disease. As the frequency of migraine attacks increase, so does proportionally the child's disability in lost school time and family and social interactions, all of which may lead in turn to economic disability. Studies estimate the health care costs are 70% higher for a family with a migraine than a non-migraine affected family, and direct medical costs for children with migraine are reported to be similar to those for adults. A study published in JAMA 2003 found that health care costs, work-related disability for parents and lost educational opportunity for the child leads to an annual economic impact in the US of approximately $36 billion due to both direct medical costs and lost productivity into adulthood.
Onaboutlinum (BOTOX) is currently FDA approved as a very successful treatment to prevent migraines in adults, however not yet children. Current treatments for migraine in children appear to be insufficient. No trials currently exist in literature prospectively studying onabotulinumtoxinA for efficacy and/or safety for indication of pediatric migraine, although significant contributions have been made by retrospective case series over the last 10 years.
This research will be the first investigator-initiated study to study BOTOX (R) in children prospectively in a randomized controlled placebo, cross-over study. The overriding rationale is to demonstrate efficacy, tolerability and safety of onabotulinumtoxinA for pediatric migraine and thereby potentially hasten the lengthy process to evaluate BOTOX® for approval in the pediatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA/Saline Placebo | Other | The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. |
|
| Saline Placebo/OnabotulinumtoxinA | Other | The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Drug | The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Migraines | The frequency of migraines in days. | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Intensity of Migraines | Median intensity of migraines based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain. | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Migraine Duration, in Hours | Duration of migraines in hours. | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Pediatric Migraine Disability Score (PedMIDAS) | Pediatric Migraine Disability Score consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months. The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4). | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality Improvement | Improvement of functionality as determined by their Pediatric Migraine Disability Score (PedMIDAS). The PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months. The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4). |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Migraines | Open-label Period | The frequency of migraines during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period. | 24-48 weeks post-baseline period |
| Intensity of Migraines | Open-Label Period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shalini S Shah, MD | Assistant Clinical Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gottschalk Medical Plaza | Irvine | California | 92697 | United States | ||
| UC Irvine Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21883197 | Background | Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29. | |
| 20487038 | Background |
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Pediatric subjects aged 8 to 17 were recruited during an enrollment window from March 1st, 2017 to November 30th, 2018 at the UCI Health Center for Pain and Wellness located at UCI Health's Gottschalk Medical Plaza.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cross-over: OnabotulinumtoxinA, Then Saline Placebo | The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second. Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2021 |
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|
|
| Placebo (Saline) | Other | The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. |
|
| Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Difficulty Sleeping | Subject reported having difficulty sleeping | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Hospital Admissions | Admission to hospital | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Emergency Department (ED) Visits | Subject visited an Emergency Department | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Home School | Subject is home schooled full-time. | Baseline (4 weeks) and 12 weeks post, respective intervention |
| School Plan Enrollment | Subject is enrolled in a school plan such as IEP, 504 plan, or similar modified school schedule. | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Duration of Benefit | The duration of benefit in weeks | Baseline (4 weeks) and 12 weeks post each, respective intervention |
| Concomitant Headache Medications | Number of concomitant headache medications taken | Baseline (4 weeks) and 12 weeks post each, respective intervention |
Intensity of migraines during the the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period. Intensity based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain. |
| 24-48 weeks post-baseline period |
| Pediatric Migraine Disability Score (PedMIDAS) | Open-Label Period | The PedMIDAS the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period. The PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months. The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4). | 24-48 weeks post-baseline period |
| Duration of Migraine | Open-Label Period | Duration of migraine in hours during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period. | 24-48 weeks post-baseline period |
| Orange |
| California |
| 92868 |
| United States |
| Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010 Jun;50(6):921-36. doi: 10.1111/j.1526-4610.2010.01678.x. Epub 2010 May 7. |
| 20933173 | Background | Ahmed K, Oas KH, Mack KJ, Garza I. Experience with botulinum toxin type A in medically intractable pediatric chronic daily headache. Pediatr Neurol. 2010 Nov;43(5):316-9. doi: 10.1016/j.pediatrneurol.2010.06.001. |
| 23303551 | Background | Bonfert M, Straube A, Schroeder AS, Reilich P, Ebinger F, Heinen F. Primary headache in children and adolescents: update on pharmacotherapy of migraine and tension-type headache. Neuropediatrics. 2013 Feb;44(1):3-19. doi: 10.1055/s-0032-1330856. Epub 2013 Jan 9. |
| 26521123 | Background | Brodsky JR, Cusick BA, Zhou G. Evaluation and management of vestibular migraine in children: Experience from a pediatric vestibular clinic. Eur J Paediatr Neurol. 2016 Jan;20(1):85-92. doi: 10.1016/j.ejpn.2015.09.011. Epub 2015 Oct 22. |
| 19835236 | Background | Chan VW, McCabe EJ, MacGregor DL. Botox treatment for migraine and chronic daily headache in adolescents. J Neurosci Nurs. 2009 Oct;41(5):235-43. doi: 10.1097/jnn.0b013e3181aaa98f. |
| 7596620 | Background | Hermann C, Kim M, Blanchard EB. Behavioral and prophylactic pharmacological intervention studies of pediatric migraine: an exploratory meta-analysis. Pain. 1995 Mar;60(3):239-55. doi: 10.1016/0304-3959(94)00210-6. |
| 23594025 | Background | Hershey AD, Powers SW, Coffey CS, Eklund DD, Chamberlin LA, Korbee LL; CHAMP Study Group. Childhood and Adolescent Migraine Prevention (CHAMP) study: a double-blinded, placebo-controlled, comparative effectiveness study of amitriptyline, topiramate, and placebo in the prevention of childhood and adolescent migraine. Headache. 2013 May;53(5):799-816. doi: 10.1111/head.12105. Epub 2013 Apr 17. |
| 22288433 | Background | Jacobs H, Gladstein J. Pediatric headache: a clinical review. Headache. 2012 Feb;52(2):333-9. doi: 10.1111/j.1526-4610.2011.02086.x. Epub 2012 Jan 30. |
| 22274570 | Background | Kabbouche M, O'Brien H, Hershey AD. OnabotulinumtoxinA in pediatric chronic daily headache. Curr Neurol Neurosci Rep. 2012 Apr;12(2):114-7. doi: 10.1007/s11910-012-0251-1. |
| 24760491 | Background | Kacperski J, Hershey AD. Preventive drugs in childhood and adolescent migraine. Curr Pain Headache Rep. 2014 Jun;18(6):422. doi: 10.1007/s11916-014-0422-7. |
| 25772998 | Background | Yonker M, Mangum T. Migraine management in children. Curr Neurol Neurosci Rep. 2015 May;15(5):20. doi: 10.1007/s11910-015-0540-6. |
| 26695061 | Background | Tajti J, Szok D, Csati A, Vecsei L. Prophylactic Drug Treatment of Migraine in Children and Adolescents: An Update. Curr Pain Headache Rep. 2016 Jan;20(1):1. doi: 10.1007/s11916-015-0536-6. |
| 33106278 | Derived | Shah S, Calderon MD, Crain N, Pham J, Rinehart J. Effectiveness of onabotulinumtoxinA (BOTOX) in pediatric patients experiencing migraines: a randomized, double-blinded, placebo-controlled crossover study in the pediatric pain population. Reg Anesth Pain Med. 2021 Jan;46(1):41-48. doi: 10.1136/rapm-2020-101605. Epub 2020 Oct 26. |
| FG001 | Cross-over: Saline Placebo, Then OnabotulinumtoxinA | The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. |
| FG002 | Open Label Botox | Following unblinding, subject elected Botox treatment for 24 week open-label period where all subjects receive Botox treatment. |
| FG003 | Open Label Standard of Care | Following unblinding, subject elected to a 24-week return to conservative management per standard-of-care protocols. |
| COMPLETED |
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| NOT COMPLETED |
|
| Open-Label Period |
|
|
15 subjects randomized into the baseline, double-blind period (cross-over).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cross-Over: OnabotulinumtoxinA, Then Saline Placebo | The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. OnabotulinumtoxinA: The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. Placebo (Saline): The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. |
| BG001 | Cross-Over: Saline Placebo, Then OnabotulinumtoxinA | The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. OnabotulinumtoxinA: The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. Placebo (Saline): The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. |
| BG002 | 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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 | Frequency of Migraines | The frequency of migraines in days. | Posted | Median | Inter-Quartile Range | days | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Primary | Intensity of Migraines | Median intensity of migraines based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Primary | Migraine Duration, in Hours | Duration of migraines in hours. | Posted | Median | Inter-Quartile Range | hours | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Primary | Pediatric Migraine Disability Score (PedMIDAS) | Pediatric Migraine Disability Score consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months. The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4). | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Secondary | Functionality Improvement | Improvement of functionality as determined by their Pediatric Migraine Disability Score (PedMIDAS). The PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months. The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4). | Baseline acted as control so no data for Functionality Improvement collected from participants at baseline. | Posted | Median | Full Range | score on a scale | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Secondary | Difficulty Sleeping | Subject reported having difficulty sleeping | Posted | Count of Participants | Participants | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Secondary | Hospital Admissions | Admission to hospital | Posted | Count of Participants | Participants | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Secondary | Emergency Department (ED) Visits | Subject visited an Emergency Department | Posted | Count of Participants | Participants | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Secondary | Home School | Subject is home schooled full-time. | Posted | Count of Participants | Participants | Baseline (4 weeks) and 12 weeks post, respective intervention |
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| Secondary | School Plan Enrollment | Subject is enrolled in a school plan such as IEP, 504 plan, or similar modified school schedule. | Posted | Count of Participants | Participants | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Secondary | Duration of Benefit | The duration of benefit in weeks | No data collected from participants at 4-week baseline in order to act as the control. | Posted | Median | Inter-Quartile Range | weeks | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Secondary | Concomitant Headache Medications | Number of concomitant headache medications taken | Posted | Median | Inter-Quartile Range | number taken | Baseline (4 weeks) and 12 weeks post each, respective intervention |
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| Other Pre-specified | Frequency of Migraines | Open-label Period | The frequency of migraines during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period. | 15 subjects completed the cross-over period. Of those 15, 11 continued Botox (2 lost to follow-up), and 4 elected conservative management (1 discontinued intervention) | Posted | Median | Inter-Quartile Range | days | 24-48 weeks post-baseline period |
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| Other Pre-specified | Intensity of Migraines | Open-Label Period | Intensity of migraines during the the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period. Intensity based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain. | 15 subjects completed the cross-over period. Of those 15, 11 continued Botox (2 lost to follow-up), and 4 elected conservative management (1 discontinued intervention) | Posted | Median | Inter-Quartile Range | units on a scale | 24-48 weeks post-baseline period |
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| Other Pre-specified | Pediatric Migraine Disability Score (PedMIDAS) | Open-Label Period | The PedMIDAS the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period. The PedMIDAS consists of 6 questions: 3 addressing school attendance and functioning, and 3 evaluating participation in events outside of school. The questionnaire is based on the patient's recall of the previous 3 months. The questionnaire produces a raw score (0-10, 11-30, 31-50, >50) corresponding to a disability grade with increasing severity (little to non, mild, moderate, and severe) which was coded (1, 2, 3, and 4). | After the unblinding visit, 11 subjects elected to continue with the open-label period and were scheduled to receive two additional rounds of OBTA treatment (2 were lost to follow up). 4 subjects elected to receive standard of care (1 discontinued intervention). | Posted | Median | Inter-Quartile Range | score on a scale | 24-48 weeks post-baseline period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Duration of Migraine | Open-Label Period | Duration of migraine in hours during the open-label period (2 additional rounds of onabotulinumtoxinA) as compared to the cross-over period. | After the unblinding visit, 11 subjects elected to continue with the open-label period and were scheduled to receive two additional rounds of OBTA treatment (2 were lost to follow up). 4 subjects elected to receive standard of care (1 discontinued intervention). | Posted | Median | Inter-Quartile Range | hours | 24-48 weeks post-baseline period |
|
1 year
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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 | Cross-over: OnabotulinumtoxinA/Saline Placebo | The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second. Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG001 | Cross-over: Saline Placebo/OnabotulinumtoxinA | The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Off Label Botox: | Following unblinding, subject elected Botox treatment for 24 week open-label period where all subjects receive Botox treatment. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Off Label Standard of Care: | Following unblinding, subject elected to a 24-week return to conservative management per standard-of-care protocols. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
A lack of diversity in subject demographics and age. Didn't control for patients seeking alternative therapies during the study period, nor attempt to control concomitant medications.
Patients with comorbidities can have an impact on the treatment effect. PedMIDAS may not account for seasonal changes or patients with modified school schedules.
Continuation of baseline therapy is a confounding variable. Pain diary records required follow-up. Data collection relied in part on subject recall.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shalini Shah, MD | University of California, Irvine | Dept. of Anesthesiology & Perioperative Care | (949) 824-7246 | ssshah1@hs.uci.edu |
| May 31, 2023 |
| Prot_SAP_000.pdf |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Withdrawal by Subject |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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| Open-Label Period | Standard-of-Care |
Subjects unblinded and elected to continue with standard care pain consultation (conservative management). |
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| Units | Counts |
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| Participants |
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