Bringing Relief to Adolescents Naturally Using Melatonin for Migraine

Exclusion Criteria

• •1. Currently (or within the last 4 weeks) using any medication or device with migraine preventive properties: i.e. topiramate, amitriptyline, nortriptyline, propranolol, metoprolol, sodium valproate, gabapentin, flunarizine, methysergide, riboflavin, butterbur, coenzyme Q10, or the Cefaly TENS device. For onabotulinum toxin, they will have to have been off it for at least three months
• •2. Use of other sleep medication or sedating medication, such as benzodiazepines, trazodone, or melatonin receptor agonists
• •3. History of allergy or adverse event with previous use of exogenous melatonin
• •4. Previous ineffective trial of melatonin 3 mg nightly for migraine prevention, where the trial duration was at least three months in duration
• •5. Inability to swallow pills, if this inability persists after instruction on pill-swallowing techniques
• •6. History of epilepsy or seizure
• •7. Overuse of acute headache medications, wherein medication overuse is defined33 as ≥4 days per month of barbiturate containing compounds, ≥10 days per month of opioid containing compounds, or ≥10 days per month of triptans or ergot-containing compounds. Those using non-specific analgesics ≥15 days per month would also be excluded
• •8. Adolescent does not have the cognitive capacity to give verbal assent to participate, or the investigator thinks the adolescent does not have the cognitive capacity to complete the diary, even with parental assistance
• •9. For females: Pregnancy, lactating or planning to become pregnant during the study. For males: planning to father a child during the study
• •10. Abnormal neurologic examination findings
• •11. Serious medical illness of any kind; seriousness as judged by the investigator
• •12. The investigator does not think the participant can comply with study procedures, or does not think it is medically appropriate for the participant to be in the study