Bringing Relief to Adolescents Naturally Using Melatonin for Migraine

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine in Adolescents

In brief

Migraine in adolescents is common and effective and safe preventive treatments are needed. This is a pilot randomized controlled trial of melatonin versus placebo for migraine prevention in adolescents 12-17 years old.

Key facts

Study ID

NCT02344316

Run by

Amy Gelfand

People needed

31

Starts

2015-05-01

Expected to finish

2016-04-01

Last updated by the study team

2021-09-09

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 12-17 years and weight ≥40 kg, to allow consistent dosing for all participants of the melatonin dose that has been found to be effective in adults
• Resides in California
• Headache fulfills International Classification for Headache Disorders, Third Edition (beta version)33 criteria for episodic migraine (with or without aura) in adolescents
• Has been experiencing episodic headaches for at least six months
• Experiences between 6-14 days of migraine/migrainous headaches per month at baseline (cutoff for chronic migraine is ≥15 days/month)
• Developmentally able to provide age-appropriate level of assent
• Has a parent/guardian capable of giving written informed consent
• Has daily access to a smartphone in order to be able to complete daily study procedures such as diary completion, and to receive text reminders
• Subject and parent agree the adolescent will not use over-the-counter melatonin, or another migraine preventive medication, while participating in the study
• Participant and at least one parent speak English

You may not qualify if…

• 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
• Use of other sleep medication or sedating medication, such as benzodiazepines, trazodone, or melatonin receptor agonists
• History of allergy or adverse event with previous use of exogenous melatonin
• Previous ineffective trial of melatonin 3 mg nightly for migraine prevention, where the trial duration was at least three months in duration
• Inability to swallow pills, if this inability persists after instruction on pill-swallowing techniques
• History of epilepsy or seizure
• 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
• 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
• For females: Pregnancy, lactating or planning to become pregnant during the study. For males: planning to father a child during the study
• Abnormal neurologic examination findings
• Serious medical illness of any kind; seriousness as judged by the investigator
• 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

Where it is running

• UCLA Headache Research and Treatment Program — Los Angeles, California, United States
• UCSF Pediatric Brain Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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