Trial Outcomes & Findings for Treatment of Acute Migraine Headache in Children (NCT NCT00355394)

Results Overview

The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

2 hours

Results posted on

2015-11-30

Participant Flow

Subjects recruited from tertiary care emergency department (ED). N=31.

Participant milestones

Participant milestones
Measure	Placebo Placebo group received standard care including IVF but not metoclopramide.	Metoclopramide Metoclopramide group received standard care including IVF and also IV metoclopramide.
Overall Study STARTED	15	16
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Acute Migraine Headache in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=15 Participants Placebo group received standard care including IVF but not metoclopramide.	Metoclopramide n=16 Participants Metoclopramide group received standard care including IVF AND metoclopramide.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	10.8 years STANDARD_DEVIATION 3.1 • n=93 Participants	12.9 years STANDARD_DEVIATION 2.4 • n=4 Participants	11.9 years STANDARD_DEVIATION 2.9 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	8 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	16 participants n=4 Participants	31 participants n=27 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: All participants included.

The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo	Metoclopramide n=16 Participants Metoclopramide
The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.	5 participants	12 participants

SECONDARY outcome

Timeframe: 1 hour

Population: All participants included.

The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo	Metoclopramide n=16 Participants Metoclopramide
The Number of Subjects With a NRS Score of Zero at One Hour.	1 participants	9 participants

SECONDARY outcome

Timeframe: 24 hours

The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo	Metoclopramide n=16 Participants Metoclopramide
The Number of Subjects With a NRS Score of Zero at 24 Hours.	4 participants	7 participants

SECONDARY outcome

Timeframe: 1 hours

Population: All participants included.

The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo	Metoclopramide n=16 Participants Metoclopramide
Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment.	-2.5 NRS Score Standard Deviation 2.5	-6.8 NRS Score Standard Deviation 3.1

SECONDARY outcome

Timeframe: 2 hours

The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo	Metoclopramide n=16 Participants Metoclopramide
Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment.	-4.9 NRS Score Standard Deviation 2.8	-7.8 NRS Score Standard Deviation 2.1

SECONDARY outcome

Timeframe: 24 hours

The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo	Metoclopramide n=16 Participants Metoclopramide
Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment.	-4.5 NRS Score Standard Deviation 2.9	-5.6 NRS Score Standard Deviation 3.3

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoclopramide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nicholas Abend

CHOP

Phone: 215-590-1719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place