MAP: Melatonin for Adolescent Migraine Prevention Study

Sponsor

Amy Gelfand (Other)

Overall Status

Terminated

CT.gov ID

NCT03150797

Collaborator

University of California, Los Angeles (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Melatonin Drug: Placebo oral capsule	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Melatonin for Adolescent Migraine Prevention Study (The MAP Study).

Actual Study Start Date :

Aug 2, 2017

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin 3mg Melatonin 3mg	Drug: Melatonin Melatonin
Experimental: Melatonin 6mg Melatonin 6mg	Drug: Melatonin Melatonin
Placebo Comparator: Placebo oral capsule Placebo	Drug: Placebo oral capsule Placebo

Arm

Intervention/Treatment

Experimental: Melatonin 3mg

Melatonin 3mg

Drug: Melatonin

Melatonin

Experimental: Melatonin 6mg

Melatonin 6mg

Drug: Melatonin

Melatonin

Placebo Comparator: Placebo oral capsule

Placebo

Drug: Placebo oral capsule

Placebo

Outcome Measures

Primary Outcome Measures

Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin treated participants vs. placebo. [weeks 5-8 of randomized treatment phase]
Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin treated participants vs. placebo.

Secondary Outcome Measures

Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 6 mg vs. placebo. [Weeks 5-8 of randomized treatment phase.]
Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 6 mg vs. placebo.
Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 3 mg vs. placebo. [Weeks 5-8 of randomized treatment phase.]
Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 3 mg vs. placebo.
Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 6 mg vs. melatonin 3 mg. [Weeks 5-8 of randomized treatment phase.]
Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 6 mg vs. melatonin 3 mg.
Change in mean migraine/migrainous days from weeks 5-8 of single-blind treatment phase to weeks 5-8 of randomized treatment phase for each group. [Weeks 5-8 of single-blind treatment phase to weeks 5-8 of randomized treatment phase.]
Change in mean migraine/migrainous days from weeks 5-8 of single-blind treatment phase to weeks 5-8 of randomized treatment phase for each group.
Mean PedMIDAS (headache related disability score) in weeks 5-8 of randomized treatment phase in each melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [Weeks 5-8 of randomized treatment phase.]
Mean PedMIDAS (headache related disability score) in weeks 5-8 of randomized treatment phase in each melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons.
Mean CASQ score in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [Weeks 5-8 of randomized treatment phase.]
Mean CASQ score in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons.
Number of days acute medication is used in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [Weeks 5-8 of randomized treatment phase.]
Number of days acute medication is used in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons.
Number of headache days in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [Weeks 5-8 of randomized treatment phase.]
Number of headache days in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 10-17-inclusive
Weight ≥40 kg, so as not to require mg/kg based dosing
Meets International Classification of Headache Disorders III beta1 criteria for migraine in children/adolescents (international standard diagnostic criteria for research)
Lives in the state of California- to allow shipping of study medication from our pharmacy
Has at least one parent who speaks English-in order to ensure good communication with study team by phone
Has daily access to a smartphone in order to provide daily headache diary data
A Parent/Guardian consents and the adolescent is cognitively capable of giving assent to participate
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
Willing to not use OTC melatonin or change migraine preventives during the trial
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:

Continuous headache
History of seizures/epilepsy
Pregnant/lactating
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
If in the investigator's opinion there is a medical or psychiatric concern that makes them think the participant should not participate
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:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Headache Research and Treatment Program	Los Angeles	California	United States	90077
2	University of California, San Francisco, (UCSF)	San Francisco	California	United States	94158