Overview

This trial has been completed.

Condition migraine in adolescents
Treatments melatonin, placebo
Phase phase 2
Sponsor University of California, San Francisco
Collaborator University of California, Los Angeles
Start date May 2015
End date April 2016
Trial size 31 participants
Trial identifier NCT02344316, 14-14251

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Group randomized to melatonin 3 mg orally nightly
melatonin
Taken at 9 PM or 1 hour before bedtime, whichever is earlier
(Placebo Comparator)
Group randomized to placebo orally nightly
placebo
Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier

Primary Outcomes

Measure
Variance in migraine/migrainous days per 28 day period in melatonin group and placebo group (As measured using an online/mobile device headache diary)
time frame: Month 3 of treatment vs. 28 day run-in

Secondary Outcomes

Measure
Variance in mean sleep onset latency, total sleep time, and sleep efficiency (As measured using mobile actigraphy)
time frame: Month 3 of treatment vs. 28 day run-in
Compare mean number of migraine/migrainous days in melatonin group vs. placebo
time frame: Month 3 of treatment vs. 28 day run in
Number of participants recruited from each recruitment strategy
time frame: During the enrollment period, approximately 1 year
Medication adherence rate
time frame: during the "At Home Active Study Period" or Weeks 5-16
Headache Diary compliance rate
time frame: Weeks 12-16 of the study

Eligibility Criteria

Male or female participants from 12 years up to 17 years old.

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

Additional Information

Official title Melatonin for Migraine Prevention in Adolescents: A Pilot Remote Trial: "The BRAiN-M Study"
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.