Migraine in AdolescentsPhase 2BRAiN-MNCT02344316
Bringing Relief to Adolescents Naturally Using Melatonin for Migraine
A Phase 2 study testing Melatonin in people with Migraine in Adolescents, run by Amy Gelfand at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Migraine in Adolescents
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Headache Research and Treatment Program
Los Angeles, California, 90077
UCSF Pediatric Brain Center
San Francisco, California, 94158
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine in Adolescents
- Being tested
- Melatonin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Rugby melatonin
Taken at 9 PM or 1 hour before bedtime, whichever is earlier
PlaceboOther
Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | Group randomized to melatonin 3 mg orally nightly Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Group randomized to placebo orally nightly Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Migraine/Migrainous Days Per 28 Day Period
Number of Migraine/Migrainous Days Per 28 Day Period in melatonin group and placebo group as measured using an online/mobile device headache diary.
Measured: final 4 weeks of treatment
Secondary outcomes (4)
Number of Minutes to Sleep Onset
Number of minutes to sleep onset as measured by a FitBit.
Measured: 16 weeks
Number of Participants Recruited From Each Recruitment Strategy
Each recruitment strategy will be analyzed for number of participants successfully enrolled.
Measured: During the enrollment period, approximately 1 year
Medication Adherence as Measured by Number of Openings Per Participant
eCAP tack caps will be used to measure medication adherence and the number of openings will be recorded per participant.
Measured: during the "At Home Active Study Period" or Weeks 5-16
Headache Diary Compliance Rate
Number of participants that had ≥85% headache diary compliance during weeks 12-16 of the study.
Measured: Weeks 12-16 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Migraine in AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amy Gelfand
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor-investigator, Amy Gelfand, University of California, San Francisco
- Investigators
- Amy A Gelfand, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344316
- Sponsor's protocol ID
- 14-14251
- Acronym
- BRAiN-M
- Status last verified
- Aug 2021
- First submitted
- 12 Jan 2015
- Last updated
- 9 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masruha MR, Lin J, de Souza Vieira DS, Minett TS, Cipolla-Neto J, Zukerman E, Vilanova LC, Peres MF. Urinary 6-sulphatoxymelatonin levels are depressed in chronic migraine and several comorbidities. Headache. 2010 Mar;50(3):413-9. doi: 10.1111/j.1526-4610.2009.01547.x. Epub 2009 Oct 8.
PubMed 19817880Masruha MR, de Souza Vieira DS, Minett TS, Cipolla-Neto J, Zukerman E, Vilanova LC, Peres MF. Low urinary 6-sulphatoxymelatonin concentrations in acute migraine. J Headache Pain. 2008 Aug;9(4):221-4. doi: 10.1007/s10194-008-0047-5. Epub 2008 Jul 2.
PubMed 18594760Peres MF, Masruha MR, Zukerman E, Moreira-Filho CA, Cavalheiro EA. Potential therapeutic use of melatonin in migraine and other headache disorders. Expert Opin Investig Drugs. 2006 Apr;15(4):367-75. doi: 10.1517/13543784.15.4.367.
PubMed 16548786Peres MF, Zukerman E, da Cunha Tanuri F, Moreira FR, Cipolla-Neto J. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.
PubMed 15326268Peres MF, Sanchez del Rio M, Seabra ML, Tufik S, Abucham J, Cipolla-Neto J, Silberstein SD, Zukerman E. Hypothalamic involvement in chronic migraine. J Neurol Neurosurg Psychiatry. 2001 Dec;71(6):747-51. doi: 10.1136/jnnp.71.6.747.
PubMed 11723194Fallah R, Shoroki FF, Ferdosian F. Safety and efficacy of melatonin in pediatric migraine prophylaxis. Curr Drug Saf. 2015;10(2):132-5. doi: 10.2174/1574886309666140605114614.
PubMed 24909684
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin for Migraine Prevention in Adolescents: A Pilot Remote Trial: "The BRAiN-M Study"
- ClinicalTrials.gov ID
- NCT02344316
- Acronym / sponsor ID
- BRAiN-M / 14-14251
- Conditions
- Migraine in Adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Amy GelfandUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Posted 9 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: MelatoninGroup randomized to melatonin 3 mg orally nightly |
| Placebo | Placebo comparator | Other: PlaceboGroup randomized to placebo orally nightly |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: Rugby melatoninTaken at 9 PM or 1 hour before bedtime, whichever is earlier | Drug | Melatonin |
| PlaceboMatching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Number of Minutes to Sleep Onset
Time frame: 16 weeks
Number of Participants Recruited From Each Recruitment Strategy
Time frame: 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
Headache Diary Compliance Rate
Time frame: Weeks 12-16 of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19817880Masruha MR, Lin J, de Souza Vieira DS, Minett TS, Cipolla-Neto J, Zukerman E, Vilanova LC, Peres MF. Urinary 6-sulphatoxymelatonin levels are depressed in chronic migraine and several comorbidities. Headache. 2010 Mar;50(3):413-9. doi: 10.1111/j.1526-4610.2009.01547.x. Epub 2009 Oct 8.
- Background: PubMed 18594760Masruha MR, de Souza Vieira DS, Minett TS, Cipolla-Neto J, Zukerman E, Vilanova LC, Peres MF. Low urinary 6-sulphatoxymelatonin concentrations in acute migraine. J Headache Pain. 2008 Aug;9(4):221-4. doi: 10.1007/s10194-008-0047-5. Epub 2008 Jul 2.
- Background: PubMed 16548786Peres MF, Masruha MR, Zukerman E, Moreira-Filho CA, Cavalheiro EA. Potential therapeutic use of melatonin in migraine and other headache disorders. Expert Opin Investig Drugs. 2006 Apr;15(4):367-75. doi: 10.1517/13543784.15.4.367.
- Background: PubMed 15326268Peres MF, Zukerman E, da Cunha Tanuri F, Moreira FR, Cipolla-Neto J. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.
- Background: PubMed 11723194Peres MF, Sanchez del Rio M, Seabra ML, Tufik S, Abucham J, Cipolla-Neto J, Silberstein SD, Zukerman E. Hypothalamic involvement in chronic migraine. J Neurol Neurosurg Psychiatry. 2001 Dec;71(6):747-51. doi: 10.1136/jnnp.71.6.747.
- Background: PubMed 24909684Fallah R, Shoroki FF, Ferdosian F. Safety and efficacy of melatonin in pediatric migraine prophylaxis. Curr Drug Saf. 2015;10(2):132-5. doi: 10.2174/1574886309666140605114614.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy A Gelfand, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Migraine in Adolescents, run by Amy Gelfand at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Migraine/Migrainous Days Per 28 Day Period (time frame: final 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02344316, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.