Bringing Relief to Adolescents Naturally Using Melatonin for Migraine

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Migraine in Adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

Group randomized to melatonin 3 mg orally nightly

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

Taken at 9 PM or 1 hour before bedtime, whichever is earlier

Placebo

Group randomized to placebo orally nightly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier

Interventions

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Melatonin

Taken at 9 PM or 1 hour before bedtime, whichever is earlier

Intervention Type DRUG

Placebo

Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier

Intervention Type OTHER

Other Intervention Names

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Rugby melatonin

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Resides in California
3. Headache fulfills International Classification for Headache Disorders, Third Edition (beta version)33 criteria for episodic migraine (with or without aura) in adolescents
4. Has been experiencing episodic headaches for at least six months
5. Experiences between 6-14 days of migraine/migrainous headaches per month at baseline (cutoff for chronic migraine is ≥15 days/month)
6. Developmentally able to provide age-appropriate level of assent
7. Has a parent/guardian capable of giving written informed consent
8. 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
9. Subject and parent agree the adolescent will not use over-the-counter melatonin, or another migraine preventive medication, while participating in the study
10. Participant and at least one parent speak English

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No