Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population
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| ClinicalTrials.gov Identifier: NCT03055767 |
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Recruitment Status :
Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : April 19, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine Disorders Headache, Migraine Pediatrics | Drug: OnabotulinumtoxinA Other: Placebo (Saline) | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 17 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Randomized Double Blinded Placebo Cross-over Study in the Pediatric Pain Population |
| Actual Study Start Date : | March 1, 2017 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | January 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: 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.
Other Name: Botox Other: 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. |
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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.
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Drug: 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.
Other Name: Botox Other: 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. |
- Pain scores (Intensity) [ Time Frame: 12 months ](standardized numerical rating scale);
- Change in duration of migraine episode [ Time Frame: 12 months ](chart history)
- Frequency of Migraine [ Time Frame: 12 months ](chart history);
- Disability and Functionality [ Time Frame: 12 months ](chart history); PediMIDAS scoring
- Opioid Consumption [ Time Frame: 12 months ]Amount of opioid medication consumed (chart history)
- Duration of benefit of onabotulinumtoxinA therapy [ Time Frame: 12 months ]chart history
- Associated side effects [ Time Frame: 12 months ]incidence of nausea, vomiting, food intake, diarrhea, constipation, anxiety, depression
- Adverse Event (AE) related to onabotulinumtoxin A [ Time Frame: 12 months ](chart history)
- Rescue medication use/change [ Time Frame: 12 months ]chart review
- Hospital and Emergency Department (ED) utilization [ Time Frame: 12 months ]chart review
- Current medication use [ Time Frame: 12 months ]Increase, Decrease or no change in concomitant headache medication
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 8 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children aged 8 - 17 years of age with a history of migraine meeting the criteria established in ICHD-II (2004), Section 1. Patients will provide at least 28-day baseline data in the form in the daily diary and must have at least 15 days of reported headache during this period, with at least 4 distinct episodes lasting at least 4 hours each.
Exclusion Criteria:
- Previous use of botulinum toxin of any serotype for any reason
- Pregnancy.
- Diagnosis of Myasthenia gravis, Eaton Lambert Syndrome, Amyotrophic Lateral Sclerosis
- Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week of screening visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055767
| United States, California | |
| Gottschalk Medical Plaza | |
| Irvine, California, United States, 92697 | |
| UC Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | Shalini S Shah, MD | Assistant Clinical Professor |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT03055767 |
| Other Study ID Numbers: |
UCIANES09 [HS# 2016-3108] |
| First Posted: | February 16, 2017 Key Record Dates |
| Last Update Posted: | April 19, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Botulinum Toxins, Type A |
abobotulinumtoxinA Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents |