Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents (NCT NCT00963937)

Results Overview

Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

178 participants

Primary outcome timeframe

120 minutes post-treatment (Randomization through Final Visit [Week 6])

Results posted on

2018-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.	Sumatriptan 25 mg Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.	Sumatriptan 50 mg Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
Overall Study STARTED	89	44	45
Overall Study COMPLETED	70	33	41
Overall Study NOT COMPLETED	19	11	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.	Sumatriptan 25 mg Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.	Sumatriptan 50 mg Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
Overall Study Protocol Violation	1	1	0
Overall Study Physician Decision	18	10	4

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=70 Participants Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.	Sumatriptan 25 mg n=33 Participants Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.	Sumatriptan 50 mg n=41 Participants Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.	Total n=144 Participants Total of all reporting groups
Age, Continuous	13.9 Years STANDARD_DEVIATION 2.04 • n=5 Participants	14.5 Years STANDARD_DEVIATION 2.18 • n=7 Participants	14.1 Years STANDARD_DEVIATION 1.96 • n=5 Participants	14.1 Years STANDARD_DEVIATION 2.05 • n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants	84 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	60 Participants n=4 Participants
Race/Ethnicity, Customized	70 participants n=5 Participants	33 participants n=7 Participants	41 participants n=5 Participants	144 participants n=4 Participants

PRIMARY outcome

Timeframe: 120 minutes post-treatment (Randomization through Final Visit [Week 6])

Population: Full Analysis Set (FAS): all participants in the Safety Population (all participants who took \>=1 dose of investigational product \[IP\]) who provided any post-treatment efficacy assessment. Analysis was performed on the last observation carried forward (LOCF) dataset (imputed by LOCF method). Only post-treatment values were used for imputation.

Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.