Migraine in Adolescents Clinical Trial
— BRAiN-MOfficial title:
Melatonin for Migraine Prevention in Adolescents: A Pilot Remote Trial: "The BRAiN-M Study"
| NCT number | NCT02344316 |
| Other study ID # | 14-14251 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | May 2015 |
| Est. completion date | April 2016 |
| Verified date | August 2021 |
| Source | University of California, San Francisco |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | UCLA Headache Research and Treatment Program | Los Angeles | California |
| United States | UCSF Pediatric Brain Center | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Amy Gelfand | University of California, Los Angeles |
United States,
Fallah R, Shoroki FF, Ferdosian F. Safety and efficacy of melatonin in pediatric migraine prophylaxis. Curr Drug Saf. 2015;10(2):132-5. — View Citation
Masruha 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. — View Citation
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. — View Citation
Peres 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. Review. — View Citation
Peres 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. — View Citation
Peres 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | final 4 weeks of treatment | |
| Secondary | Number of Minutes to Sleep Onset | Number of minutes to sleep onset as measured by a FitBit. | 16 weeks | |
| Secondary | Number of Participants Recruited From Each Recruitment Strategy | Each recruitment strategy will be analyzed for number of participants successfully enrolled. | During the enrollment period, approximately 1 year | |
| Secondary | 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. | during the "At Home Active Study Period" or Weeks 5-16 | |
| Secondary | Headache Diary Compliance Rate | Number of participants that had =85% headache diary compliance during weeks 12-16 of the study. | Weeks 12-16 of the study |