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

August 13, 2021 updated by: Amy Gelfand

Melatonin for Migraine Prevention in Adolescents: A Pilot Remote Trial: "The BRAiN-M Study"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90077
        • UCLA Headache Research and Treatment Program
      • San Francisco, California, United States, 94158
        • UCSF Pediatric Brain Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin
Group randomized to melatonin 3 mg orally nightly
Drug: Melatonin
Taken at 9 PM or 1 hour before bedtime, whichever is earlier
Other Names:
  • Rugby melatonin
Placebo Comparator: Placebo
Group randomized to placebo orally nightly
Other: Placebo
Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Migraine/Migrainous Days Per 28 Day Period
Time Frame: final 4 weeks of treatment
Number of Migraine/Migrainous Days Per 28 Day Period in melatonin group and placebo group as measured using an online/mobile device headache diary.
final 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Minutes to Sleep Onset
Time Frame: 16 weeks
Number of minutes to sleep onset as measured by a FitBit.
16 weeks
Number of Participants Recruited From Each Recruitment Strategy
Time Frame: During the enrollment period, approximately 1 year
Each recruitment strategy will be analyzed for number of participants successfully enrolled.
During the enrollment period, approximately 1 year
Medication Adherence as Measured by Number of Openings Per Participant
Time Frame: during the "At Home Active Study Period" or Weeks 5-16
eCAP tack caps will be used to measure medication adherence and the number of openings will be recorded per participant.
during the "At Home Active Study Period" or Weeks 5-16
Headache Diary Compliance Rate
Time Frame: Weeks 12-16 of the study
Number of participants that had ≥85% headache diary compliance during weeks 12-16 of the study.
Weeks 12-16 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amy Gelfand

Collaborators

University of California, Los Angeles

Investigators

  • Principal Investigator: Amy A Gelfand, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-14251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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