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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
178
One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
Two Sumatriptan 25mg tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
Two Matching Placebo tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Hokkaido, Japan
Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment
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.
Time frame: 120 minutes post-treatment (Randomization through Final Visit [Week 6])
Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment
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.
Time frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])
Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment
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.
Time frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])
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GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hyōgo, Japan
GSK Investigational Site
Hyōgo, Japan
GSK Investigational Site
Kagoshima, Japan
GSK Investigational Site
Kanagawa, Japan
GSK Investigational Site
Kanagawa, Japan
GSK Investigational Site
Kanagawa, Japan
...and 6 more locations
Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment
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.
Time frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])
Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment
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.
Time frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])
Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment
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.
Time frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])
Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment
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.
Time frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])
Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment
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).
Time frame: within 240 minutes post-treatment (Randomization through Final Visit [Week 6])