Bringing Relief to Adolescents Naturally Using Melatonin for Migraine (BRAiN-M)

Amy Gelfand

Status and phase

Completed

Phase 2

Conditions

Migraine in Adolescents

Treatments

Other: Placebo

Drug: Melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT02344316

14-14251

Details and patient eligibility

About

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.

Full description

This is a pilot randomized controlled trial of melatonin vs. placebo for migraine prevention in adolescents 12-17 years old. The main goal of this pilot study is to estimate variance in the outcome measures to help with planning the future fully powered study. Participants will have an in person enrollment visit, followed by phone follow up visits and headache diary data collection via smart phone or internet.

Enrollment

31 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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