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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children

Brief Summary: 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment [ Time Frame: 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.


Original Primary Outcome: Percentage of subjects who report pain-relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment [ Time Frame: Within 240min post-treatment ]

Current Secondary Outcome:

  • Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 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.
  • Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 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.
  • Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 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.
  • Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 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.
  • Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 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.
  • Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 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.
  • Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment [ Time Frame: 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).


Original Secondary Outcome:

  • Proportion of subjects who used rescue medication between the time of dosing to 240 minutes [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are free of vomiting at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who report pain-relief at 30, 60, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are pain-free at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are free of photophobia at 30, 60, 120, and 240 minutes [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are free of phonophobia at 30, 60, 120, and 240 minutes [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are free of nausea at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ]


Information By: GlaxoSmithKline

Dates:
Date Received: August 20, 2009
Date Started: September 2009
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016