Melatonin for Adolescent Migraine Prevention Study

• Status: Terminated
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amy Gelfand
• Collaborator: University of California, Los Angeles
• Treatments: Melatonin

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.