Trial Outcomes & Findings for CHOCOlate MeLatonin for AdolescenT MigrainE (NCT NCT03597529)
NCT ID: NCT03597529
Last Updated: 2021-06-15
Results Overview
Visual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Baseline (Time 0) and 2 hours
Results posted on
2021-06-15
Participant Flow
Recruitment ran from September 25, 2017 until November 5, 2019. Eligibility was assessed by a pediatric headache specialist.
Out of 102 participants who were assessed for eligibility, 84 met inclusion criteria and were randomized to a treatment.
Participant milestones
| Measure |
Low-Dose Melatonin (mg)
melatonin 2mg (equal to or over 40kg)
melatonin 1mg (under 40kg)
Melatonin: melatonin
|
High-Dose Melatonin (mg)
melatonin 8mg (equal to or over 40kg)
melatonin 4mg (under 40kg)
Melatonin: melatonin
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
Follow-up
|
22
|
24
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
20
|
18
|
Reasons for withdrawal
| Measure |
Low-Dose Melatonin (mg)
melatonin 2mg (equal to or over 40kg)
melatonin 1mg (under 40kg)
Melatonin: melatonin
|
High-Dose Melatonin (mg)
melatonin 8mg (equal to or over 40kg)
melatonin 4mg (under 40kg)
Melatonin: melatonin
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
12
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Non-compliant with study activities
|
1
|
2
|
Baseline Characteristics
Data on this baseline measurement is missing for one participant. While there are 84 participants total in the study, there is sex data for 83 participants total.
Baseline characteristics by cohort
| Measure |
Low-Dose Melatonin (mg)
n=42 Participants
melatonin 2mg (equal to or over 40kg)
melatonin 1mg (under 40kg)
Melatonin: melatonin
|
High-Dose Melatonin (mg)
n=42 Participants
melatonin 8mg (equal to or over 40kg)
melatonin 4mg (under 40kg)
Melatonin: melatonin
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
42 Participants
n=42 Participants
|
42 Participants
n=42 Participants
|
84 Participants
n=84 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=84 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=84 Participants
|
|
Age, Continuous
|
11.8 years
STANDARD_DEVIATION 3.5 • n=42 Participants
|
11.7 years
STANDARD_DEVIATION 3.6 • n=42 Participants
|
11.8 years
STANDARD_DEVIATION 3.5 • n=84 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=42 Participants • Data on this baseline measurement is missing for one participant. While there are 84 participants total in the study, there is sex data for 83 participants total.
|
23 Participants
n=41 Participants • Data on this baseline measurement is missing for one participant. While there are 84 participants total in the study, there is sex data for 83 participants total.
|
46 Participants
n=83 Participants • Data on this baseline measurement is missing for one participant. While there are 84 participants total in the study, there is sex data for 83 participants total.
|
|
Sex: Female, Male
Male
|
19 Participants
n=42 Participants • Data on this baseline measurement is missing for one participant. While there are 84 participants total in the study, there is sex data for 83 participants total.
|
18 Participants
n=41 Participants • Data on this baseline measurement is missing for one participant. While there are 84 participants total in the study, there is sex data for 83 participants total.
|
37 Participants
n=83 Participants • Data on this baseline measurement is missing for one participant. While there are 84 participants total in the study, there is sex data for 83 participants total.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
42 participants
n=42 Participants
|
42 participants
n=42 Participants
|
84 participants
n=84 Participants
|
|
Weight (kg)
|
45.7 kg
STANDARD_DEVIATION 18.0 • n=42 Participants
|
53.1 kg
STANDARD_DEVIATION 25.6 • n=42 Participants
|
49.3 kg
STANDARD_DEVIATION 22.1 • n=84 Participants
|
|
Headache days per month (self report)
|
5.5 days per month
STANDARD_DEVIATION 4.1 • n=42 Participants
|
5.8 days per month
STANDARD_DEVIATION 3.4 • n=42 Participants
|
5.6 days per month
STANDARD_DEVIATION 3.8 • n=84 Participants
|
|
Aura
|
10 Participants
n=35 Participants • Analysis population differs from the Overall number of baseline participants because data was not provided for this measure by all participants.
|
6 Participants
n=33 Participants • Analysis population differs from the Overall number of baseline participants because data was not provided for this measure by all participants.
|
16 Participants
n=68 Participants • Analysis population differs from the Overall number of baseline participants because data was not provided for this measure by all participants.
|
|
Reason(s) for dissatisfaction with previous acute medications
Ineffective
|
9 participants
n=42 Participants
|
8 participants
n=42 Participants
|
17 participants
n=84 Participants
|
|
Reason(s) for dissatisfaction with previous acute medications
Side effects
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
2 participants
n=84 Participants
|
|
Reason(s) for dissatisfaction with previous acute medications
Prefer natural options
|
24 participants
n=42 Participants
|
24 participants
n=42 Participants
|
48 participants
n=84 Participants
|
|
Reason(s) for dissatisfaction with previous acute medications
Other
|
14 participants
n=42 Participants
|
9 participants
n=42 Participants
|
23 participants
n=84 Participants
|
|
Currently on migraine preventive
|
19 Participants
n=38 Participants • Analysis population differs from the Overall number of baseline participants because data was not provided for this measure by all participants.
|
14 Participants
n=35 Participants • Analysis population differs from the Overall number of baseline participants because data was not provided for this measure by all participants.
|
33 Participants
n=73 Participants • Analysis population differs from the Overall number of baseline participants because data was not provided for this measure by all participants.
|
|
Melatonin Dose/Weight
|
0.04 mg/kg
STANDARD_DEVIATION 0.01 • n=42 Participants
|
0.13 mg/kg
STANDARD_DEVIATION 0.03 • n=42 Participants
|
0.08 mg/kg
STANDARD_DEVIATION 0.05 • n=84 Participants
|
PRIMARY outcome
Timeframe: Baseline (Time 0) and 2 hoursVisual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain.
Outcome measures
| Measure |
Low-Dose Melatonin (mg)
n=22 Participants
melatonin 2mg (equal to or over 40kg)
melatonin 1mg (under 40kg)
Melatonin: melatonin
|
High-Dose Melatonin (mg)
n=24 Participants
melatonin 8mg (equal to or over 40kg)
melatonin 4mg (under 40kg)
Melatonin: melatonin
|
|---|---|---|
|
Change in Mean Visual Analog Scale (VAS) Score
|
-2.3 cm
Standard Deviation 2.1
|
-2.7 cm
Standard Deviation 2.1
|
Adverse Events
Low-Dose Melatonin (mg)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
High-Dose Melatonin (mg)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low-Dose Melatonin (mg)
n=19 participants at risk
melatonin 2mg (equal to or over 40kg)
melatonin 1mg (under 40kg)
Melatonin: melatonin
|
High-Dose Melatonin (mg)
n=21 participants at risk
melatonin 8mg (equal to or over 40kg)
melatonin 4mg (under 40kg)
Melatonin: melatonin
|
|---|---|---|
|
Nervous system disorders
Proportion who napped within 2 hours after treating
|
47.4%
9/19 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
66.7%
14/21 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
|
Nervous system disorders
Fatigue
|
10.5%
2/19 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
19.0%
4/21 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
|
Nervous system disorders
Weakness
|
0.00%
0/19 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
4.8%
1/21 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/19 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
4.8%
1/21 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
0.00%
0/21 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
0.00%
0/21 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
0.00%
0/21 • Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
|
Additional Information
Dr. Amy A. Gelfand
Director, Child and Adolescent Headache Program, UCSF Benioff Children's Hospitals
Phone: 415-502-1914
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place