Melatonin for Adolescent Migraine Prevention Study (MAP)

Amy Gelfand

Status and phase: Terminated; Phase 2

Conditions: Migraine

Treatments: Drug: Placebo oral capsule; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT03150797

16-19623

Details and patient eligibility

About

This will be a randomized, multi-site double-blind placebo-controlled trial of melatonin (2 different dosing arms) vs. placebo for migraine prevention in adolescents. We intend to enroll approximately 210 participants over 15 months at two sites: UCLA and UCSF. The duration of participation for each participant will be 4 months.

Full description

Participation includes 16 weeks of daily headache diary recording and taking the study pill every night, 1-2 hours before bed. Aside from the initial 1 hour enrollment visit, all remaining study procedures will be completed from home.

During the enrollment visit, history of migraine, questionnaires, a neurologic and physical exam (including weight, blood pressure, pulse, and respiratory rate) will be performed. Girls who have had their first period will undergo a urine pregnancy test and will be instructed to use birth control if they are sexually active.

For the first 8 week phase, participants will be instructed to take one study pill every night, 1-2 hours before bedtime and complete a daily headache diary from a smartphone. Phone call check-ins will occur at week 4 and week 8.

After the first 8 weeks of the study, participants who are eligible for the second phase of the study will be notified by study staff and will be sent the next set of study pills. Again, participants will be instructed to take the study pill every night, 1-2 hours before bedtime and complete a diary entry every evening.

Phone call check-ins will occur at week 12 and week 16. At the final 16 week phone call, additional questionnaires and study completion feedback will be collected.

Enrollment: 72 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 10-17-inclusive
2. Weight ≥40 kg, so as not to require mg/kg based dosing
3. Meets International Classification of Headache Disorders III beta1 criteria for migraine in children/adolescents (international standard diagnostic criteria for research)
4. Lives in the state of California- to allow shipping of study medication from our pharmacy
5. Has at least one parent who speaks English-in order to ensure good communication with study team by phone
6. Has daily access to a smartphone in order to provide daily headache diary data
7. A Parent/Guardian consents and the adolescent is cognitively capable of giving assent to participate
8. Either not on a migraine preventive medication, or if on one the dose has been stable for at least 4 weeks prior to enrollment, or are willing to wait to start the study until they have reached a stable dose for 4 weeks
9. Willing to not use OTC melatonin or change migraine preventives during the trial
10. Has ≥1 headache day per week, or 4-28 days of headache in a 28-day period Episodic headaches have been present for a minimum of 6 months-This lowers the likelihood of a secondary cause of headaches

Exclusion criteria

1. Continuous headache
2. History of seizures/epilepsy
3. Pregnant/lactating
4. Concomitant opioid or barbiturate overuse, wherein overuse is defined as ≥4 days per month of barbiturate containing compounds, ≥10 days per month of opioid containing compounds as these may impact sleepiness scales
5. If in the investigator's opinion there is a medical or psychiatric concern that makes them think the participant should not participate
6. Inability to swallow pills after teaching and practice History of nocturnal asthma, as evidenced by a having a diagnosis of asthma and symptoms that manifest as nighttime awakening due to cough, wheeze, and/or shortness of breath

Randomization Criteria:

1. Had 4-28 migraine/migrainous days in the 28-day period of weeks 5-8 of single-blind placebo treatment phase, but not continuous headache.
2. At least 80% compliance with headache diary (i.e. at least 23 headache diary days) during weeks 5-8 of single-blind placebo treatment phase.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups, including a placebo group

Melatonin 3mg

Experimental group

Description:

Melatonin 3mg

Treatment:

Drug: Melatonin

Melatonin 6mg

Experimental group

Description:

Melatonin 6mg

Treatment:

Drug: Melatonin

Placebo oral capsule

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo oral capsule