NCT00963937

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

Completed Phase 3 Results posted Last updated 6 August 2018

What this trial tests

Phase 3 trial testing Sumatriptan 25 mg in Migraine Disorders in 178 participants. Completed in 3 December 2010.

Timeline

28 September 2009

Primary endpoint
1 December 2010

3 December 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	178
Start date	28 September 2009
Primary completion	1 December 2010
Estimated completion	3 December 2010
Sites	16 locations across Japan

Drugs / interventions tested

• Sumatriptan 25 mg — full drug profile →
• Sumatriptan 50 mg — full drug profile →
• Placebo

Conditions studied

• Migraine Disorders — all drugs for Migraine Disorders →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 10 to 17, any sex, with Migraine Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment Primary · 120 minutes post-treatment (Randomization through Final Visit [Week 6])

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.

Group	Value	95% CI
Placebo	38.6
Sumatriptan Pooled	31.1

Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment Secondary · 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

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.

30 minutes post-treatment

Group	Value	95% CI
Placebo	4.3
Sumatriptan 25 mg	0
Sumatriptan 50 mg	9.8
Sumatriptan Pooled	5.4

60 minutes post-treatment

Group	Value	95% CI
Placebo	18.6
Sumatriptan 25 mg	9.1
Sumatriptan 50 mg	7.3
Sumatriptan Pooled	8.1

120 minutes post-treatment

Group	Value	95% CI
Placebo	38.6
Sumatriptan 25 mg	33.3
Sumatriptan 50 mg	29.3
Sumatriptan Pooled	31.1

240 minutes post-treatment

Group	Value	95% CI
Placebo	51.4
Sumatriptan 25 mg	66.7
Sumatriptan 50 mg	61.0
Sumatriptan Pooled	63.5

Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment Secondary · 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

Pain free was defined as a post-treatment pain intensity score of 1 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 a rescue medication. 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.

30 minutes post-treatment

Group	Value	95% CI
Placebo	2.9
Sumatriptan 25 mg	0
Sumatriptan 50 mg	2.4
Sumatriptan Pooled	1.4

60 minutes post-treatment

Group	Value	95% CI
Placebo	12.9
Sumatriptan 25 mg	3.0
Sumatriptan 50 mg	2.4
Sumatriptan Pooled	2.7

120 minutes post-treatment

Group	Value	95% CI
Placebo	28.6
Sumatriptan 25 mg	24.2
Sumatriptan 50 mg	19.5
Sumatriptan Pooled	21.6

240 minutes post-treatment

Group	Value	95% CI
Placebo	47.1
Sumatriptan 25 mg	63.6
Sumatriptan 50 mg	39.0
Sumatriptan Pooled	50.0

Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment Secondary · 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

Photophobia (sensitivity to light) is one of the associated symptoms of a migraine. A participant was assessed as photophobia free when the symptom was recorded as "absent" at each time point in his or her patient diary. Photophobia was recorded as "present" for all subsequent assessments if a participant took rescue medication.

30 minutes post-treatment

Group	Value	95% CI
Placebo	16.7
Sumatriptan 25 mg	13.3
Sumatriptan 50 mg	15.4
Sumatriptan Pooled	14.3

60 minutes post-treatment

Group	Value	95% CI
Placebo	44.4
Sumatriptan 25 mg	26.7
Sumatriptan 50 mg	38.5
Sumatriptan Pooled	32.1

120 minutes post-treatment

Group	Value	95% CI
Placebo	52.8
Sumatriptan 25 mg	60.0
Sumatriptan 50 mg	46.2
Sumatriptan Pooled	53.6

240 minutes post-treatment

Group	Value	95% CI
Placebo	69.4
Sumatriptan 25 mg	80.0
Sumatriptan 50 mg	69.2
Sumatriptan Pooled	75.0

Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment Secondary · 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

Phonophobia (sensitivity to sound) is one of the associated symptoms of a migraine. A participant was assessed as phonophobia free when the symptom was recorded as "absent" at each time point in his or her patient diary. Phonophobia was recorded as "present" for all subsequent assessments if a participant took rescue medication.

30 minutes post-treatment

Group	Value	95% CI
Placebo	22.7
Sumatriptan 25 mg	50.0
Sumatriptan 50 mg	12.5
Sumatriptan Pooled	30.0

60 minutes post-treatment

Group	Value	95% CI
Placebo	45.5
Sumatriptan 25 mg	57.1
Sumatriptan 50 mg	25.0
Sumatriptan Pooled	40.0

120 minutes post-treatment

Group	Value	95% CI
Placebo	63.6
Sumatriptan 25 mg	64.3
Sumatriptan 50 mg	43.8
Sumatriptan Pooled	53.3

240 minutes post-treatment

Group	Value	95% CI
Placebo	72.7
Sumatriptan 25 mg	78.6
Sumatriptan 50 mg	68.8
Sumatriptan Pooled	73.3

Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment Secondary · 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

Nausea is one of the associated symptoms of a migraine. A participant was assessed as nausea free when the symptom was recorded as "absent" at each time point in his or her patient diary. Nausea was recorded as "present" for all subsequent assessments if a participant took rescue medication.

30 minutes post-treatment

Group	Value	95% CI
Placebo	47.6
Sumatriptan 25 mg	40.0
Sumatriptan 50 mg	12.5
Sumatriptan Pooled	27.8

60 minutes post-treatment

Group	Value	95% CI
Placebo	66.7
Sumatriptan 25 mg	40.0
Sumatriptan 50 mg	12.5
Sumatriptan Pooled	27.8

120 minutes post-treatment

Group	Value	95% CI
Placebo	81.0
Sumatriptan 25 mg	70.0
Sumatriptan 50 mg	50.0
Sumatriptan Pooled	61.1

240 minutes post-treatment

Group	Value	95% CI
Placebo	81.0
Sumatriptan 25 mg	70.0
Sumatriptan 50 mg	50.0
Sumatriptan Pooled	61.1

Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment Secondary · 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

Vomiting is one of the associated symptoms of a migraine. A participant was assessed as being free of vomiting when the symptom was recorded as "absent" at each time point in his or her patient diary. Vomiting was recorded as "present" for all subsequent assessments if a participant took a rescue medication.

30 minutes post-treatment

Group	Value	95% CI
Sumatriptan 25 mg	0
Sumatriptan Pooled	0

60 minutes post-treatment

Group	Value	95% CI
Sumatriptan 25 mg	0
Sumatriptan Pooled	0

120 minutes post-treatment

Group	Value	95% CI
Sumatriptan 25 mg	100.0
Sumatriptan Pooled	100.0

240 minutes post-treatment

Group	Value	95% CI
Sumatriptan 25 mg	100.0
Sumatriptan Pooled	100.0

Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment Secondary · within 240 minutes post-treatment (Randomization through Final Visit [Week 6])

Rescue medication included one of the following: a single oral dose of a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, not to exceed the maximum recommended single dose; and anti-emetics (a drug to prevent vomiting).

Group	Value	95% CI
Placebo	12.9
Sumatriptan 25 mg	12.1
Sumatriptan 50 mg	14.6
Sumatriptan Pooled	13.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (AEs) and non-serious AEs were collected from the start of IP through follow-up contact (6 weeks plus or minus 7 days).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/70 (0%)

Deaths: —

Sumatriptan 25 mg

Serious: 0/33 (0%)

Deaths: —

Sumatriptan 50 mg

Serious: 0/41 (0%)

Deaths: —

Sumatriptan Pooled

Serious: 0/74 (0%)

Deaths: —

Other adverse events (3 terms — click to expand)

Reaction	System	Placebo	Sumatriptan 25 mg	Sumatriptan 50 mg	Sumatriptan Pooled
Blood creatine phosphokinase increased	Investigations	—	—	—	—
Chest discomfort	General disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT00963937 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral sumatriptan for the acute treatment of migraine in children ages 10 to 17.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
   Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497