Melatonin for Adolescent Migraine Prevention Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Melatonin; Placebo oral capsule
Intervention description: Melatonin; Placebo
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 72.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: UCSF; UCLA; melatonin; migraine; headache

Summary:

      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.
    

Eligibility criteria:

        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.