Migraine DisordersPhase 2NCT03055767

Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population

A Phase 2 study testing OnabotulinumtoxinA in people with Migraine Disorders and Headache, Migraine, run by University of California, Irvine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 8 to 17 years
Conditions the study is for: Migraine Disorders, Headache, Migraine, Pediatrics
What is being tested?: OnabotulinumtoxinA
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 2 sitesUnited States
Study dates: 1 Mar 2017to 20 Apr 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Gottschalk Medical Plaza
Irvine, California, 92697
UC Irvine Medical Center
Orange, California, 92868

Other trials in United States

About this study

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

Read the detailed description

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.

Conditions: Migraine Disorders, Headache, Migraine, Pediatrics
Being tested: OnabotulinumtoxinA, Placebo (Saline)
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OnabotulinumtoxinADrug
Also called Botox
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)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.

Study groups in NCT03055767
Study group	Role	What they receive
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. Receives: Drug: OnabotulinumtoxinA; Other: Placebo (Saline)
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. Receives: Drug: OnabotulinumtoxinA; Other: Placebo (Saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Migraines
The frequency of migraines in days.
Measured: 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.
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention
Migraine Duration, in Hours
Duration of migraines in hours.
Measured: 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).
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention

Secondary outcomes (8)

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).
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention
Difficulty Sleeping
Subject reported having difficulty sleeping
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention
Hospital Admissions
Admission to hospital
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention
Emergency Department (ED) Visits
Subject visited an Emergency Department
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention
Home School
Subject is home schooled full-time.
Measured: 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.
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention
Duration of Benefit
The duration of benefit in weeks
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention
Concomitant Headache Medications
Number of concomitant headache medications taken
Measured: Baseline (4 weeks) and 12 weeks post each, respective intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201720 Apr 2020

First posted16 Feb 2017
Study start1 Mar 2017
Primary completion30 Nov 2018
Study completion20 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Migraine DisordersStudies of the same condition, open and under way.
More trials run by University of California, IrvineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03055767
Sponsor's protocol ID: 20163108
Other IDs: UCIANES09
Status last verified: Sep 2023
First submitted: 8 Feb 2017
Last updated: 18 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21883197
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.
PubMed 20487038
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.
PubMed 20933173
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.
PubMed 23303551
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.
PubMed 26521123
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.
PubMed 19835236
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.
PubMed 7596620
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.
PubMed 23594025
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.
PubMed 22288433
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.
PubMed 22274570
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.
PubMed 24760491
Yonker M, Mangum T. Migraine management in children. Curr Neurol Neurosci Rep. 2015 May;15(5):20. doi: 10.1007/s11910-015-0540-6.
PubMed 25772998
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.
PubMed 26695061
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.
PubMed 33106278

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Migraine Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03055767
Acronym / sponsor ID: 20163108
Conditions: Migraine Disorders, Headache, Migraine, Pediatrics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of California, IrvineUniversity, hospital or other
Collaborators: American Society of Regional Anesthesia
Study start: 1 Mar 2017 (actual)
Primary completion: 30 Nov 2018 (actual)
Study completion: 20 Apr 2020 (actual)
First posted: 16 Feb 2017 (actual)
Results: Posted 18 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
OnabotulinumtoxinA/Saline Placebo	Other	Drug: OnabotulinumtoxinA, Other: Placebo (Saline)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	Drug: OnabotulinumtoxinA, 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.

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OnabotulinumtoxinAAlso: BotoxThe 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.	Drug	OnabotulinumtoxinA/Saline Placebo, Saline Placebo/OnabotulinumtoxinA
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.	Other	OnabotulinumtoxinA/Saline Placebo, Saline Placebo/OnabotulinumtoxinA

Primary outcome

Frequency of Migraines
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
The frequency of migraines in days.
Intensity of Migraines
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Median intensity of migraines based on 0-10 Pain Numeric Rating Score (NRS). The higher the score, the more intense the pain.
Migraine Duration, in Hours
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Duration of migraines in hours.
Pediatric Migraine Disability Score (PedMIDAS)
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
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).

8 secondary outcomes

Functionality Improvement
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Difficulty Sleeping
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Hospital Admissions
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Emergency Department (ED) Visits
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Home School
Time frame: Baseline (4 weeks) and 12 weeks post, respective intervention
School Plan Enrollment
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Duration of Benefit
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention
Concomitant Headache Medications
Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention

Results and safety

Results posted to the registry on 18 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cross-over: OnabotulinumtoxinA, Then Saline Placebo	9	9
Cross-over: Saline Placebo, Then OnabotulinumtoxinA	6	6
Open Label Botox	0	0
Open Label Standard of Care	0	0

Primary outcome: Frequency of Migraines

Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention. Median (Inter-Quartile Range). Unit: days

Measure	Baseline Period \| Control n = 15	Botox Period n = 15	Placebo Period n = 15
Value	28 (20 to 28)	20 (7 to 28)	28 (23 to 28)

Baseline Period | Control vs Botox Period vs Placebo Period: p = 0.038, Wilcoxon signed-rank test

Primary outcome: Intensity of Migraines

Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Baseline Period \| Control n = 15	Botox Period n = 15	Placebo Period n = 15
Value	8 (7 to 10)	5 (3 to 7)	7 (5 to 9)

Baseline Period | Control vs Botox Period vs Placebo Period: p = 0.047, Wilcoxon signed-rank test)

Primary outcome: Migraine Duration, in Hours

Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention. Median (Inter-Quartile Range). Unit: hours

Measure	Baseline Period \| Control n = 15	Botox Period n = 15	Placebo Period n = 15
Value	24 (13 to 24)	10 (2 to 24)	24 (4 to 24)

Baseline Period | Control vs Botox Period vs Placebo Period: p = 0.148, Wilcoxon signed-rank test)

Primary outcome: Pediatric Migraine Disability Score (PedMIDAS)

Time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Baseline Period \| Control n = 15	Botox Period n = 15	Placebo Period n = 15
Value	4 (4 to 4)	3 (2 to 4)	4 (4 to 4)

Baseline Period | Control vs Botox Period vs Placebo Period: p = 0.047, Wilcoxon signed-rank test)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cross-over: OnabotulinumtoxinA/Saline Placebo	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Cross-over: Saline Placebo/OnabotulinumtoxinA	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Off Label Botox:	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Off Label Standard of Care:	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21883197Aurora 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.
Background: PubMed 20487038Dodick 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.
Background: PubMed 20933173Ahmed 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.
Background: PubMed 23303551Bonfert 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.
Background: PubMed 26521123Brodsky 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.
Background: PubMed 19835236Chan 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.
Background: PubMed 7596620Hermann 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.
Background: PubMed 23594025Hershey 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.
Background: PubMed 22288433Jacobs 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.
Background: PubMed 22274570Kabbouche 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.
Background: PubMed 24760491Kacperski 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.
Background: PubMed 25772998Yonker M, Mangum T. Migraine management in children. Curr Neurol Neurosci Rep. 2015 May;15(5):20. doi: 10.1007/s11910-015-0540-6.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shalini S Shah, MD principal investigator

Assistant Clinical Professor

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OnabotulinumtoxinA in people with Migraine Disorders and Headache, Migraine, run by University of California, Irvine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Migraines (time frame: Baseline (4 weeks) and 12 weeks post each, respective intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03055767, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.