Trial Outcomes & Findings for Bringing Relief to Adolescents Naturally Using Melatonin for Migraine (NCT NCT02344316)

NCT ID: NCT02344316

Last Updated: 2021-09-09

Results Overview

Number of Migraine/Migrainous Days Per 28 Day Period in melatonin group and placebo group as measured using an online/mobile device headache diary.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: final 4 weeks of treatment
• Results posted on: 2021-09-09

Participant Flow

There was a 28 day baseline run-in prior to randomization.

Participant milestones

Measure	Melatonin Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier	Placebo Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
Overall Study STARTED	13	13
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bringing Relief to Adolescents Naturally Using Melatonin for Migraine

Baseline characteristics by cohort

Measure	Melatonin n=13 Participants Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier	Placebo n=13 Participants Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15 years STANDARD_DEVIATION 1.2 • n=5 Participants	14.1 years STANDARD_DEVIATION 1.7 • n=7 Participants	14.5 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: final 4 weeks of treatment

Number of Migraine/Migrainous Days Per 28 Day Period in melatonin group and placebo group as measured using an online/mobile device headache diary.

Outcome measures

Measure	Melatonin n=12 Participants Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier	Placebo n=11 Participants Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
Number of Migraine/Migrainous Days Per 28 Day Period	3.6 days Standard Error 0.9	4.9 days Standard Error 1.7

SECONDARY outcome

Timeframe: 16 weeks

Number of minutes to sleep onset as measured by a FitBit.

Outcome measures

Measure	Melatonin n=13 Participants Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier	Placebo n=13 Participants Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
Number of Minutes to Sleep Onset	15.2 minutes Standard Deviation 10.7	17.2 minutes Standard Deviation 12

SECONDARY outcome

Timeframe: During the enrollment period, approximately 1 year

Each recruitment strategy will be analyzed for number of participants successfully enrolled.

Outcome measures

Measure	Melatonin n=31 Participants Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier	Placebo Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
Number of Participants Recruited From Each Recruitment Strategy Newspaper advertising	3 Participants	—
Number of Participants Recruited From Each Recruitment Strategy Clinic recruitment	6 Participants	—
Number of Participants Recruited From Each Recruitment Strategy Social media advertising (eg, Facebook and Google+	11 Participants	—
Number of Participants Recruited From Each Recruitment Strategy Electronic medical record letter invitation	10 Participants	—
Number of Participants Recruited From Each Recruitment Strategy Other	1 Participants	—

SECONDARY outcome

Timeframe: during the "At Home Active Study Period" or Weeks 5-16

eCAP tack caps will be used to measure medication adherence and the number of openings will be recorded per participant.

Outcome measures

Measure	Melatonin n=12 Participants Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier	Placebo n=12 Participants Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
Medication Adherence as Measured by Number of Openings Per Participant	39 Mean Number of Openings Standard Deviation 27	60 Mean Number of Openings Standard Deviation 28

SECONDARY outcome

Timeframe: Weeks 12-16 of the study

Number of participants that had ≥85% headache diary compliance during weeks 12-16 of the study.

Outcome measures

Measure	Melatonin n=12 Participants Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier	Placebo n=11 Participants Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
Headache Diary Compliance Rate	11 Participants	10 Participants

Adverse Events

Melatonin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Melatonin n=13 participants at risk	Placebo n=13 participants at risk
General disorders Daytime tiredness	15.4% 2/13 • Number of events 2	0.00% 0/13
General disorders Unscheduled medical visit for migraine	15.4% 2/13 • Number of events 2	0.00% 0/13
Blood and lymphatic system disorders Low iron on routine labs	7.7% 1/13 • Number of events 1	0.00% 0/13
Gastrointestinal disorders Episode of vomiting	7.7% 1/13 • Number of events 1	0.00% 0/13
General disorders Fever	0.00% 0/13	7.7% 1/13 • Number of events 1
General disorders Accident	0.00% 0/13	23.1% 3/13 • Number of events 3

Additional Information

Amy Gelfand, MD

UCSF Pediatric Headache Program

Phone: 415-885-7832

Email: Amy.Gelfand@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place