Migraine in childhood

Information: Last updated: 23 June 2024

Migraine in childhood

Information: Calcitonin gene-related peptide (CGRP), Migraine, OnabotulinumtoxinA for migraine, headaches

Review of acute and preventative pharmacologic and non-pharmacologic treatment of pediatric migraine, including recent or ongoing clinical trials.

Index

Acute Treatment of Migraine in Pediatrics: Guidelines and Recommendations

Guidelines Overview

Published By: American Headache Society and American Academy of Neurology (Oskui M et al., 2019A; 2019B)
Year: 2019
Focus Areas:
- Prompt treatment
- Migraine characteristics and associated symptoms
- Medication formulation
- Incorporation of healthy lifestyle habits

Importance of Acute Treatment

Risks of Ineffective Treatment:
- Medication overuse headache
- Progression to chronic migraine
Essential Components:
- Correct headache diagnosis
- Diagnostic testing for secondary headache disorders
- Assessment of premonitory/aura symptoms, headache features, associated symptoms, and overall disability
- Goal: Quick-acting, effective therapy with minimal side effects

Medication and Treatment Options

Triptans:
- Most effective for pain relief
- Less effect on associated nausea and vomiting
Antiemetics:
- Limited clinical trials for migraine-associated nausea
- Demonstrated safety in pediatric gastroenteritis
- Recommended for significant nausea or vomiting

Counseling and Early Intervention

Over-the-Counter Medications:
- Acetaminophen, ibuprofen, naproxen
- Weight-based doses
FDA-Approved Triptans for Pediatrics:
- Rizatriptan (from age 6)
- Almotriptan, sumatriptan/naproxen, zolmitriptan nasal spray (from age 12)
Triptan Use:
- Alternative triptans if one is ineffective or causes side effects
- Two doses may be required; follow maximum daily dosing instructions

Considerations for Triptan Selection

Factors:
- Migraine-associated symptoms
- Time to peak intensity
- Disability
Multiple Triptans:
- Different migraine attacks may require different triptans
- Do not switch between triptans if the maximum daily dose is reached within 24 hours

Patient and Family Education

Trial Period:
- Finding the most effective triptan
Non-Oral Routes:
- Consider for rapid peak pain severity or prominent nausea/vomiting
Combination Therapy:
- Nonsteroidal anti-inflammatory medication (naproxen sodium) and triptan (sumatriptan) can be effective

Lifestyle and Healthy Habits

Importance:
- Healthy habits, lifestyle modifications, and avoidance of triggers
- Discuss realistic goals and expectations
Medication Overuse Headache:
- Occurs from overusing acute medication
- Secondary to ineffective preventative and acute treatment plans

Contraindications and Special Considerations

Triptan Contraindications:
- History of ischemic vascular disease or accessory conduction pathway disorder
Migraine with Aura:
- Safe to take triptan during aura
- Consult headache specialists for brainstem aura and hemiplegic migraines before triptan trial

New Treatments Under Study

Selective 5HT-1F Agonist: Lasmiditan
CGRP Antagonists: Studied for safety and efficacy in pediatric population
Devices: Regarded as safe for acute migraine treatment in pediatric patients

Preventative Treatment of Migraine in Pediatrics

Challenges in Preventative Management

Parental Concerns: Reluctance about daily medications for children.
Child’s Concerns: Fear of being labeled as different or damaged due to daily medication.
Insurance Issues: Coverage of treatment costs can be problematic.
Limited FDA-Approved Options: Fewer options for younger children; improvements with regulatory requirements for pediatric testing.

Current FDA Approvals

Topiramate: Approved for migraine prevention in children aged 12-17 years.
No Medications for Children Under 12: Requires clinicians to extrapolate data and rely on guidelines and expert consensus.

Expert Guidelines and Recommendations

Published By: American Headache Society and American Academy of Neurology
Year: 2019
Study Review: 15 class I-III studies on preventative treatment for migraine in under 18 age range.
Effective Treatments:
- Cinnarizine: Decreases headache frequency (not available in the USA).
- Topiramate: Decreases headache frequency.
- Propranolol: Possibly decreases headache frequency.
Combination Therapy: Cognitive behavioral therapy with amitriptyline shows greater benefit.

Unclear Efficacy in Pediatric Population

Medications Tested: Divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, flunarizine.
Results: Did not reach statistical significance in reducing headache frequency.

Recommendations for Clinicians

Preventative Treatments:
- High frequency of migraine or high disability score.
- Medication overuse.
Trial Period: Minimum of 2 months for preventive treatment (unless side effects require cessation).
Folic Acid Supplementation: For topiramate or divalproex in child-bearing potential demographic.

Additional Pharmacologic Choices

Cyproheptadine:
- FDA-approved for allergic rhinitis in children aged 2 years and older.
- Suggested for prevention in cyclic vomiting and migraine.
Gabapentin:
- FDA-approved for partial onset epilepsy in children aged 3 years and older.
- Used for chronic pain; small studies suggest use in pediatric migraine.

Need for Further Research

Pediatric Studies: More research needed on medications used for migraine prevention in pediatric population.
Shared Decision-Making: Essential to promote appropriate therapeutic milieu and manage expectations.

Considerations for Specific Cases

Failure of Standard Options: Use of cyproheptadine or gabapentin may be considered.
Comorbid Conditions:
- Cyproheptadine: Comorbid cyclic vomiting.
- Gabapentin: Chronic pain conditions like fibromyalgia.

Conclusion

Importance of Research: Further studies are necessary for medications currently in use and those approved for adults but not yet for children under 18.

Childhood and Adolescent Migraine Prevention Study (CHAMP)

Overview

Publication Year: 2017 (Powers SW et al., 2016 )
Type: Randomized, double-blind, placebo-controlled clinical trial
Objective: Guide preventive management in pediatric migraine
Participants: Children and adolescents aged 8-17 years with migraine
Inclusion Criteria:
- PedMIDAS disability score: 11 to 139
- Headache frequency: 4 or more days during a 28-day baseline
Study Sites: 31 enrollment sites across the USA
Drugs Studied: Amitriptyline, topiramate, placebo
Duration: 24-week treatment period
Result: Study stopped early due to futility; no significant differences between the three groups

Key Findings

Reduction in Headache Frequency and Disability:
- Meaningful reduction observed across all groups
- Participants had a history of headaches spanning 5 to 6 years

Follow-up Study

Method: Survey-based study post-CHAMP trial (Powers SW et al., 2021)
Assessment Points: 3, 6, 12, 18, 24, 36 months after study completion
Participants:
- Initial: 205 (from original 264)
- At 36 months: 155 participants (76% retention)
Limitations: Observational nature, self-reports, potential sampling bias

Long-term Results

Headache Days:
- Decreased from 3 to 1.5 per week after 3 years
PedMIDAS Disability Scores:
- Decreased from moderate to low-mild range
Preventive Medication Use:
- Only 1 participant reported using preventive medication at the 3-year mark

Implications

Sustained Reduction: Headache frequency and disability reduction maintained long-term
Non-Pharmacologic Factors:
- Effectiveness attributed to expectations of medication response, natural disease course, cognitive behavioral therapy, lifestyle changes
Holistic Approach: Reinforces the importance of a biopsychosocial approach to migraine management in youth

OnabotulinumtoxinA for Chronic Migraine Prophylaxis in Pediatrics

Background

FDA Approval for Adults: 2010, based on the PREEMPT trials.
Usage in Pediatrics: Commonly used for chronic migraine preventive treatment.

Early Studies

Retrospective Reviews:
- Study by Shah et al.:
  - Participants: 10 patients aged 8 to 17 years
  - Treatment: OnabotulinumtoxinA injections for chronic, refractory migraine
  - Dose: Average of 188.5±32 units (higher than PREEMPT trials)
  - Results: Reduction in frequency, duration, and intensity of migraines.

2020 Multicenter Trial (Winner PK et al., 2020)

Design: Double-blinded, randomized, placebo-controlled.
Participants: 125 patients aged 12 to 17 years.
Treatment Groups:
- 155 units of onabotulinumtoxinA (n=45)
- 74 units of onabotulinumtoxinA (n=43)
- Placebo (intramuscular saline; n=37)
Results:
- Reduction in headache frequency across all groups.
- No significant difference in ≥50% reduction from baseline headache frequency or change in baseline headache hours.
- Common Adverse Effects: Neck pain, upper respiratory tract infection, migraine, musculoskeletal pain, dizziness, nasopharyngitis.
- No discontinuation due to adverse events.

Study Limitations

Placebo Response: Higher in pediatric patients compared to adults.
Sample Size: Smaller number of participants (125 vs 1384 in PREEMPT trials).
Treatment Cycles: Only one treatment cycle evaluated.

Additional Studies

Retrospective Review:
- Participants: 25 pediatric patients (Goenka A et al., 2022)
- Results: Significant improvement in headache frequency and intensity after two treatments, sustained through the 3rd and 4th treatments.
Randomized, Double-Blinded, Placebo-Controlled Crossover Study (Shah S et al., 2021):
- Participants: 15 patients aged 8 to 17 years.
- Results: Significant reduction in intensity and frequency of migraines compared to placebo.
- Adverse Effects: None reported.

Conclusions and Future Research

Safety and Efficacy: Supported by several studies.
Need for Further Research:
- Multi-centered, double-blinded, randomized, placebo-controlled trials.
- Evaluation of multiple treatment cycles for long-term data on efficacy and safety

Nerve Blocks for Pediatric Refractory Migraine

Overview

Indication: Considered when traditional treatment modalities fail.
Adult Studies: Well-studied and extensively used.
Pediatric Studies: Limited studies; no randomized controlled trials.

Interventional Therapies

Common Interventions:
- Occipital nerve blocks (ONB)
- Sphenopalatine ganglion (SPG) blocks

Greater Occipital Nerve Block (GON)

Usage:
- Most commonly used for chronic migraine.
- Other indications: Status migrainosus, new daily persistent headaches, post-traumatic headaches, occipital neuralgia.
Evidence:
- Positive response in pediatric patients with chronic migraine, new daily persistent headache, and post-concussive or post-traumatic headaches.
Minor Adverse Effects:
- Temporary alopecia
- Temporary headache site soreness
- Headache worsening
- Transient dizziness
- Allergic reaction
- Lightheadedness
- Injection-related anxiety

Sphenopalatine Ganglion (SPG) Block

Emerging Evidence:
- Positive results in children with refractory migraine headaches.
Studies:
- 2017 Society of International Radiology meeting: Promising results.
- Single-center retrospective pediatric study: Safe and efficacious.
- Case series: Perceived benefits for up to 3 months after repetitive SPG blocks.
Common Side Effect: Mildly unpleasant taste in the mouth.

Impact of Chronic Refractory Migraines in Pediatrics

Negative Impact:
- School performance and attendance
- Sleep quality
- Mental health
- Social capacity
- Overall physical functioning

Recommendations

Viable Options: GON and SPG blocks for mitigating chronic migraine and associated comorbidities.
Safety: Demonstrated safety in children and adolescents.
Consideration: Should be considered in the management of refractory migraines in pediatric patients.

Devices for Acute and Preventative Treatment of Migraine in Pediatrics

Overview

Several devices are now available for the acute and preventative treatment of migraine, including Cefaly®, Nerivio®, SAVI Dual™, and gammaCore™.

Cefaly® Device

FDA Clearance: For acute and preventative treatment of migraine in individuals over 18 years of age.
Mechanism: External trigeminal nerve stimulation (eTNS), targeting the trigeminal nerve with precise electrical impulses.
Study Findings:
- Esparham et al., 2021: Decreased headache intensity by an average of 2.55 + 2.48 points on the numeric rating pain scale in 7-18-year-old migraine patients (P<0.05).

Nerivio® Device

FDA Clearance: For acute treatment of migraine and recently approved for preventative treatment in individuals aged 12 and older.
Mechanism: Remote electrical neuromodulation with conditioned pain modulation (CPM), enhancing the brainstem's pain inhibition mechanism.
Study Findings:
- Hershey et al 2021.: In an open-label study including 12-17 year-olds, 71% of participants experienced pain relief, 35% achieved pain freedom within 2 hours of symptom onset, and 90% had sustained pain relief at 24 hours. No significant adverse events or study withdrawals reported.

SAVI Dual™ Device

FDA Clearance: For acute and preventative migraine treatment in individuals aged 12 and older.
Mechanism: Single transcranial magnetic stimulation (sTMS) that delivers magnetic pulses to interrupt abnormal electrical activity associated with migraine.
Study Findings:
- Irwin et al., 2018.: In an open-label pilot trial, sTMS was found to be a feasible, well-tolerated, and acceptable non-pharmacologic preventive treatment for migraine in adolescents.

gammaCore™ Device

FDA Clearance: For acute and preventative treatment of migraine in adolescents over 12 years of age.
Mechanism: Non-invasive vagus nerve stimulation (nVNS) with gentle electrical stimulation of the vagus nerve in the anterior neck.
Study Findings:
- Grazzi et al., 2017: In a small open-label study including 13-18 year-olds, 46.8% of attacks were effectively treated without the need for rescue medication, and no device-related adverse events were reported.

Conclusion

Efficacy and Safety: All four devices (Cefaly®, Nerivio®, SAVI Dual™, and gammaCore™) have shown promising results in reducing migraine frequency and intensity in pediatric patients.
Non-Pharmacologic Options: These devices offer alternatives to medication, potentially reducing the risk of medication-related side effects.
Consideration: These devices should be considered as part of a comprehensive approach to managing migraine in pediatric patients.

Anti-Calcitonin Gene-Related Peptide (CGRP) Treatment Recommendations

Role of CGRP in Migraine

Presence: In trigeminal ganglion, released during migraine attacks.
Elevation: Serum CGRP levels are elevated during migraine attacks and chronically elevated in chronic migraine.

Monoclonal Antibodies in Pediatrics

Usage History: Used for years in pediatric immunologic and oncologic disorders.
Targeting CGRP: Limited use and ongoing research in pediatrics.
Adult Trials: Anti-CGRP monoclonal antibodies have shown efficacy for migraine prevention with good tolerability and minimal safety risks in adults.
Considerations for Pediatrics:
- Based on adult data.
- Special attention to age, pubertal state, and medical co-morbidities.

Caution in Prescribing

Expression of CGRP: Found in central and peripheral nervous systems and other body tissues.
Pediatric Populations:
- Children with compromised blood-brain barrier or peripheral nerve injury.
- Bone disease or osteopenia.
- Known immunodeficiency or on immunosuppressive therapy.
- Cardiac disease.
- Pregnant adolescent females.
First-Line Treatments: Oral preventative medications, cognitive behavioral therapy, neuromodulation devices, and nutraceutical treatments due to potential safety risks.

Recommendations by American Headache Society

Eligible Patients:
- Post-pubertal adolescents who have failed ≥2 preventative medications.
- Frequent migraines (≥8 headaches per month) with moderate or severe migraine-related disability (measured by PedMIDAS).
- Younger children with refractory migraines or chronic headache disorders (e.g., new daily persistent headache, chronic post-traumatic headache, cluster headache) with careful monitoring.

Ongoing Studies

Safety and Efficacy Evaluations: Several studies underway for children and adolescents.
Multicenter Retrospective Study:
- Reported by Greene KA et al., 2021:
  - Participants: Adolescents with chronic headache disorders or baseline continuous headache.
  - Findings: Over two-thirds showed improvement in headache severity, frequency, and functional improvement.
  - Side Effects: Similar to adults (injection site reactions, constipation, fatigue).

Ongoing Pediatric Trials for CGRP Antagonists and Related Treatments (Szperka CL et al., 2018)

Background on CGRP Receptor Antagonists

Development Challenges: Initial attempts were hampered by poor bioavailability and hepatotoxicity concerns.
Recent Approvals: Several treatments targeting CGRP or its receptors have received FDA approval in adults.

Anti-CGRP Monoclonal Antibodies

Types and Targets:
- Erenumab: Targets the CGRP receptor.
- Fremanezumab, Galcanezumab, Eptinezumab: Target CGRP itself.
Administration:
- Eptinezumab: Intravenous infusion.
- Erenumab, Fremanezumab, Galcanezumab: Subcutaneous injections.
Tolerability:
- Generally well tolerated in adults.
- Erenumab: Associated with significant constipation in some patients.
- Common side effects: Injection site reactions.

Ongoing Pediatric Phase III Trials

Purpose: Evaluate the use of the four antibodies for prevention of episodic and chronic migraine in children and adolescents.

CGRP Receptor Antagonists

Rimegepant:
- Usage: Studied for acute treatment and prevention of migraine in adults.
- Tolerability: Generally well tolerated, most common side effect is nausea.
- Pediatric Trials: Ongoing studies for both acute and preventative treatment in pediatric population (Croop R et al., 2020).
Atogepant:
- Approval: For prevention of migraine in adults.
- Common Side Effects: Constipation and nausea.
- Pediatric Trials: Planned phase III clinical study in children and adolescents (not yet started recruiting) (Ailani J et al., 2021).

Selective 5HT-1F Receptor Agonist

Lasmiditan:
- Mechanism: Inhibits the release of neurotransmitters like CGRP and glutamate in the trigeminal ganglion and trigeminal nucleus caudalis.
- Advantages: Does not cause vasoconstriction, can be used when triptans are contraindicated.
- Adult Efficacy: Established for acute treatment of migraine.
- Common Side Effects: Dizziness, somnolence, fatigue, paresthesia.
- Pediatric Trials: Ongoing phase III trial for acute treatment of migraine in patients aged 6-17 years with episodic migraine headaches (Goadsby PJ et al., 2019).

Summary of Efficacy and Tolerability

Efficacy: All treatments have shown statistically significant efficacy over placebo in adult trials, comparable to other treatment options.
Tolerability: Improved tolerability may be an advantage for some newer treatments.
Future Prospects: If pediatric trials confirm efficacy, these treatments will offer important additional options for patients unable to tolerate or respond to other treatments

References

Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, et al. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021;385(8):695–706. https://doi.org/10.1056/NEJMoa2035908.

Banerjee S, Butcher R. Pharmacological interventions for chronic pain in pediatric patients: a review of guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health. 2020. Available from: https://www.ncbi.nlm.nih. gov/books/NBK563527.

Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51–60. https://doi.org/10.1016/S0140- 6736(20)32544-7. Epub 2020 Dec 15

Dance L, Aria D, Schaefer C, Kaye R, Yonker M, Towbin R. Safety and efficacy of sphenopalatine ganglion blockade in children: initial experience. J Vasc Interv Radiol. 2017;282:2(Supplement S8).

Esparham A, Boorigie M, Ablatt S, Connelly M, Bickel J. Improving acute treatment of pediatric primary headache disorders with a novel headache treatment center: retrospective review of preliminary outcomes. J Child Neurol. 2021;36(1):54–9. https://doi.org/10.1177/0883073820952997.

Goadsby PJ, Wietecha LA, Dennehy EB, Kuca B, Case MG, Aurora SK, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019;142(7):1894–904. https://doi.org/10.1093/brain/ awz134.

Goenka A, Yu SG, George MC, Chikkannaiah M, MacDonald S, Stolfi A, et al. Is Botox right for me: when to assess the efficacy of the Botox injection for chronic migraine in pediatric population. Neuropediatrics. 2022. https://doi.org/10.1055/a-1832- 9168. Epub 2022 Apr 22.

Grazzi L, Egeo G, Liebler E, Padovan AM, Barbanti P, et al. Non-invasive vagus nerve stimulation (nVNS) as symptomatic treatment of migraine in young patients: a preliminary safety study. Neurol Sci. 2017;38(Suppl 1):197–9. https://doi.org/10. 1007/s10072-017-2942-5.

Greene KA, Gentile CP, Szperka CL, et al. Calcitonin generelated peptide monoclonal antibody use for the preventive treatment of refractory headache disorders in adolescents. Pediatr Neurol. 2021;114:62–7. https://doi.org/10.1016/j.pediatrneurol. 2020.09.014.

Hershey AD, Lin T, Gruper Y, et al. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache. 2021;61(2):310–7. https://doi.org/10.1111/head.14042.

Irwin SL, Qubty W, Allen E, Patniyot I, Goadsby PJ, Gelfand AA. Transcranial magnetic stimulation for migraine prevention in adolescents: a pilot open-label study. Headache. 2018. https:// doi.org/10.1111/head.13284.

Oskoui M, Pringsheim T, Holler-Managan Y, Potrebic S, Billinghurst L, Gloss D, et al. Practice guideline update summary: acute treatment of migraine in children and adolescents: report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2019;93(11):487–99. https://doi.org/10.1212/ WNL.0000000000008095. Epub 2019 Aug 14. Erratum in: Neurology. 2020;94(1):50. Practice guideline for pediatric migraine supported by the American Headache Society and the American Academy of Neurology.

Oskoui M, Pringsheim T, Billinghurst L, Potrebic S, Gersz EM, Gloss D, et al. Practice guideline update summary: pharmacologic treatment for pediatric migraine prevention: report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2019;93(11):500–9. https://doi.org/10.1212/WNL.0000000000008105. Epub 2019 Aug 14. Erratum in: Neurology. 2020;94(1):50. Practice guideline for pediatric migraine supported by the American Headache Society and the American Academy of Neurology

Powers SW, Hershey AD, Coffey CS, et al. The childhood and adolescent migraine prevention (CHAMP) study: a report on baseline characteristics of participants. Headache. 2016;56:859– 70. https://doi.org/10.1111/head.12810.

Powers SW, Coffey CS, Chamberlin LA, et al. Prevalence of headache days and disability 3 years after participation in the childhood and adolescent migraine prevention medication trial. JAMA Netw Open. 2021;4(7):e2114712. https://doi. org/10.1001/jamanetworkopen.2021.14712. Followup survey-based study which was conducted following the conclusion of the CHAMP trial, one of the largest and most important randomized controlled study in the pediatric population.

Rastogi RG, Hastriter EV, Evans RL, Bassal F, Hickman C, Karnik KT | display-authors=etal (2023) Advances in the Acute and Preventive Treatment of Pediatric Migraine. Curr Pain Headache Rep 27 (10):521-529. DOI: 10.1007/s11916-023-01157-8 PMID: 37561313. (Recent Review)

Shah S, Calderon MD, Wu W, Grant J, Rinehart J. OnabotulinumtoxinA (Botox®) for prophylactic treatment of pediatric migraine: a retrospective longitudinal analysis. J Child Neurol. 2018;33(9):580– 6. https://doi.org/10.1177/0883073818776142. Epub 2018 Jun 7.

Shah S, Calderon MD, Crain N, Pham J, Rinehart J. Effectiveness of onabotulinumtoxinA (Botox) in pediatric patients experiencing migraines: a randomized, double-blinded, placebocontrolled crossover study in the pediatric pain population. Reg Anesth Pain Med. 2021;46(1):41–8. https://doi.org/10.1136/ rapm-2020-101605. Epub 2020 Oct 26. 22. Ali SS, Bragin I, Rende E, Mejico L, Wer

Szperka CL, VanderPluym J, Orr SL, et al. Recommendations on the use of anti-CGRP monoclonal antibodies in children and adolescents. Headache. 2018;58(10):1658–69. https://doi.org/10.1111/ head.13414. (expert opinion paper on use of some of the newest treatments for pediatric migraine as there is no clinical trial data available in this population)

Winner PK, Kabbouche M, Yonker M, Wangsadipura V, Lum A, Brin MF. A randomized trial to evaluate onabotulinumtoxinA for prevention of headaches in adolescents with chronic migraine. Headache. 2020;60(3):564–75. https://doi.org/10.1111/head. 13754. Epub 2020 Feb 9.

Cite this: CNKE contributors.Migraine in childhood. CNKE.org, The Child Neurology Knowledge Environment. 04 January 2025. Available at: https://cnke.org/articles/358 Accessed 04 January 2025.

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