Trial Outcomes & Findings for Melatonin for Adolescent Migraine Prevention Study (NCT NCT03150797)
NCT ID: NCT03150797
Last Updated: 2023-10-13
Results Overview
Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin treated participants vs. placebo. (Ultimately, as the data were not normally distributed, medians were more appropriate).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
weeks 5-8 of randomized treatment phase
Results posted on
2023-10-13
Participant Flow
Participant milestones
| Measure |
Melatonin 3mg
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
Single-blind Placebo Run in Phase
STARTED
|
0
|
0
|
72
|
|
Single-blind Placebo Run in Phase
COMPLETED
|
0
|
0
|
59
|
|
Single-blind Placebo Run in Phase
NOT COMPLETED
|
0
|
0
|
13
|
|
Double Blind Phase
STARTED
|
14
|
14
|
14
|
|
Double Blind Phase
COMPLETED
|
10
|
10
|
7
|
|
Double Blind Phase
NOT COMPLETED
|
4
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Melatonin for Adolescent Migraine Prevention Study
Baseline characteristics by cohort
| Measure |
Melatonin 3mg
n=14 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=14 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=14 Participants
Placebo
Placebo oral capsule: Placebo
|
Enrolled in Single-blind Phase, But Did Not Randomize.
n=30 Participants
Placebo
This group constitutes those who enrolled in the study and entered the single-blind phase, but did not go on to the double-blind randomized phase.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
15.2 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
15.4 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
15.0 years
STANDARD_DEVIATION 2.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
30 participants
n=4 Participants
|
42 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: weeks 5-8 of randomized treatment phaseMean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin treated participants vs. placebo. (Ultimately, as the data were not normally distributed, medians were more appropriate).
Outcome measures
| Measure |
Melatonin 3mg
n=10 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=10 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=7 Participants
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
Mean Migraine/Migrainous Days in Weeks 5-8 of Randomized Treatment Phase in Melatonin Treated Participants vs. Placebo.
|
2 days
Interval 1.0 to 16.0
|
2 days
Interval 0.0 to 6.0
|
2 days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: 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. (Medians reported when data were not normally distributed).
Outcome measures
| Measure |
Melatonin 3mg
n=10 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=10 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=7 Participants
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
Mean Migraine/Migrainous Days in Weeks 5-8 of Randomized Treatment Phase in Melatonin 6 mg vs. Placebo.
|
2 days
Interval 1.0 to 16.0
|
2 days
Interval 0.0 to 6.0
|
2 days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Melatonin 3mg
n=10 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=10 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=7 Participants
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
Mean Migraine/Migrainous Days in Weeks 5-8 of Randomized Treatment Phase in Melatonin 3 mg vs. Placebo.
|
2 days
Interval 1.0 to 16.0
|
2 days
Interval 0.0 to 6.0
|
2 days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Melatonin 3mg
n=10 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=10 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=7 Participants
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
Mean Migraine/Migrainous Days in Weeks 5-8 of Randomized Treatment Phase in Melatonin 6 mg vs. Melatonin 3 mg.
|
2 days
Interval 1.0 to 16.0
|
2 days
Interval 0.0 to 6.0
|
2 days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: 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. (Medians reported when data were not normally distributed).
Outcome measures
| Measure |
Melatonin 3mg
n=10 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=10 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=7 Participants
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
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.
|
2 days
Interval -1.0 to 7.0
|
-1 days
Interval -3.0 to 0.0
|
0 days
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: Weeks 5-8 of randomized treatment phase.Population: Data were not collected
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. PedMIDAS is a 6 question instrument for measuring headache related disability in children and adolescents.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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. The CASQ is a 16-question instrument that uses Likert-like responses and has a score range from 16-80; higher scores indicate greater sleepiness
Outcome measures
| Measure |
Melatonin 3mg
n=10 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=8 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=6 Participants
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
Mean CASQ (Cleveland Adolescent Sleepiness Questionnaire) 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.
|
33 points
Standard Deviation 9
|
36 points
Standard Deviation 6
|
28 points
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 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. This refers to the number of days that medication for the acute treatment of headache was used during the time frame.
Outcome measures
| Measure |
Melatonin 3mg
n=10 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=10 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=7 Participants
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
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.
|
5 days
Interval 2.0 to 9.0
|
3 days
Interval 0.0 to 5.0
|
3 days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: 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. This refers to number of headache days during the time period--regardless of whether they were migraine or not.
Outcome measures
| Measure |
Melatonin 3mg
n=10 Participants
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=10 Participants
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=7 Participants
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
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.
|
8 days
Interval 3.0 to 21.0
|
4 days
Interval 1.0 to 11.0
|
5 days
Interval 1.0 to 9.0
|
Adverse Events
Melatonin 3mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Melatonin 6mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Melatonin 3mg
n=14 participants at risk
Melatonin 3mg
Melatonin: Melatonin
|
Melatonin 6mg
n=14 participants at risk
Melatonin 6mg
Melatonin: Melatonin
|
Placebo Oral Capsule
n=14 participants at risk
Placebo
Placebo oral capsule: Placebo
|
|---|---|---|---|
|
Nervous system disorders
Headache worsening
|
7.1%
1/14 • Number of events 1 • 8 week double-blind phase
|
14.3%
2/14 • Number of events 2 • 8 week double-blind phase
|
0.00%
0/14 • 8 week double-blind phase
|
|
Nervous system disorders
Headache worsening after head trauma
|
0.00%
0/14 • 8 week double-blind phase
|
0.00%
0/14 • 8 week double-blind phase
|
7.1%
1/14 • Number of events 1 • 8 week double-blind phase
|
|
Nervous system disorders
Worsened movement sensitivity
|
0.00%
0/14 • 8 week double-blind phase
|
7.1%
1/14 • Number of events 1 • 8 week double-blind phase
|
0.00%
0/14 • 8 week double-blind phase
|
|
Nervous system disorders
Nausea
|
0.00%
0/14 • 8 week double-blind phase
|
0.00%
0/14 • 8 week double-blind phase
|
7.1%
1/14 • Number of events 1 • 8 week double-blind phase
|
|
Cardiac disorders
Elevated heart rate
|
7.1%
1/14 • Number of events 1 • 8 week double-blind phase
|
0.00%
0/14 • 8 week double-blind phase
|
0.00%
0/14 • 8 week double-blind phase
|
|
Infections and infestations
Flu-like symptoms
|
0.00%
0/14 • 8 week double-blind phase
|
0.00%
0/14 • 8 week double-blind phase
|
7.1%
1/14 • Number of events 1 • 8 week double-blind phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place