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

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ClinicalTrials.gov Identifier: NCT00963937
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : August 26, 2011
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: Sumatriptan 25 mg
Drug: Sumatriptan 50 mg
Drug: Placebo
Enrollment 178
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 89 44 45
Completed 70 33 41
Not Completed 19 11 4
Reason Not Completed
Protocol Violation             1             1             0
Physician Decision             18             10             4
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 70 33 41 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 33 participants 41 participants 144 participants
13.9  (2.04) 14.5  (2.18) 14.1  (1.96) 14.1  (2.05)
[1]
Measure Description: Baseline characteristics were collected in the Full Analysis Set (FAS), comprised of all participants who took at least one dose of investigational product (IP) and provided any post-treatment efficacy assessment. Participants who withdrew from the study before completion did not receive IP and thus contributed no baseline data.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 33 participants 41 participants 144 participants
Female
39
  55.7%
17
  51.5%
28
  68.3%
84
  58.3%
Male
31
  44.3%
16
  48.5%
13
  31.7%
60
  41.7%
[1]
Measure Description: Baseline characteristics were collected in the Full Analysis Set (FAS), comprised of all participants who took at least one dose of investigational product (IP) and provided any post-treatment efficacy assessment. Participants who withdrew from the study before completion did not receive IP and thus contributed no baseline data.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 33 participants 41 participants 144 participants
70 33 41 144
[1]
Measure Description: Baseline characteristics were collected in the Full Analysis Set (FAS), comprised of all participants who took at least one dose of investigational product (IP) and provided any post-treatment efficacy assessment. Participants who withdrew from the study before completion did not receive IP and thus contributed no baseline data.
1.Primary Outcome
Title Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Sumatriptan Pooled
Hide Arm/Group Description:
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.
All participants receiving either sumatriptan 25 mg or 50 mg
Overall Number of Participants Analyzed 70 74
Measure Type: Number
Unit of Measure: percentage of participants
38.6 31.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sumatriptan Pooled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments Multiplicity was not considered because the primary analysis included a single statistical comparison.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Difference
Estimated Value -7.49
Confidence Interval (2-Sided) 95%
-23.02 to 8.04
Estimation Comments Percent difference = sumatriptan pooled group minus the placebo group
2.Secondary Outcome
Title Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the LOCF dataset.
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Hide Arm/Group Description:
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.
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.
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.
All participants receiving either sumatriptan 25 mg or 50 mg
Overall Number of Participants Analyzed 70 33 41 74
Measure Type: Number
Unit of Measure: percentage of participants
30 minutes post-treatment 4.3 0 9.8 5.4
60 minutes post-treatment 18.6 9.1 7.3 8.1
120 minutes post-treatment 38.6 33.3 29.3 31.1
240 minutes post-treatment 51.4 66.7 61.0 63.5
3.Secondary Outcome
Title Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the LOCF dataset.
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Hide Arm/Group Description:
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.
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.
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.
All participants receiving either sumatriptan 25 mg or 50 mg
Overall Number of Participants Analyzed 70 33 41 74
Measure Type: Number
Unit of Measure: percentage of participants
30 minutes post-treatment 2.9 0 2.4 1.4
60 minutes post-treatment 12.9 3.0 2.4 2.7
120 minutes post-treatment 28.6 24.2 19.5 21.6
240 minutes post-treatment 47.1 63.6 39.0 50.0
4.Secondary Outcome
Title Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the LOCF dataset. Only participants who had photophobia at the time of treatment were included in the denominator.
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Hide Arm/Group Description:
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.
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.
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.
All participants receiving either sumatriptan 25 mg or 50 mg
Overall Number of Participants Analyzed 36 15 13 28
Measure Type: Number
Unit of Measure: percentage of participants
30 minutes post-treatment 16.7 13.3 15.4 14.3
60 minutes post-treatment 44.4 26.7 38.5 32.1
120 minutes post-treatment 52.8 60.0 46.2 53.6
240 minutes post-treatment 69.4 80.0 69.2 75.0
5.Secondary Outcome
Title Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the LOCF dataset. Only participants who had phonophobia at the time of treatment were included in the denominator.
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Hide Arm/Group Description:
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.
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.
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.
All participants receiving either sumatriptan 25 mg or 50 mg
Overall Number of Participants Analyzed 22 14 16 30
Measure Type: Number
Unit of Measure: percentage of participants
30 minutes post-treatment 22.7 50.0 12.5 30.0
60 minutes post-treatment 45.5 57.1 25.0 40.0
120 minutes post-treatment 63.6 64.3 43.8 53.3
240 minutes post-treatment 72.7 78.6 68.8 73.3
6.Secondary Outcome
Title Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the LOCF dataset. Only participants who had nausea at the time of treatment were included in the denominator.
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Hide Arm/Group Description:
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.
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.
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.
All participants receiving either sumatriptan 25 mg or 50 mg
Overall Number of Participants Analyzed 21 10 8 18
Measure Type: Number
Unit of Measure: percentage of participants
30 minutes post-treatment 47.6 40.0 12.5 27.8
60 minutes post-treatment 66.7 40.0 12.5 27.8
120 minutes post-treatment 81.0 70.0 50.0 61.1
240 minutes post-treatment 81.0 70.0 50.0 61.1
7.Secondary Outcome
Title Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the LOCF dataset. Only participants who had vomiting at the time of treatment were included in the denominator.
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Hide Arm/Group Description:
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.
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.
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.
All participants receiving either sumatriptan 25 mg or 50 mg
Overall Number of Participants Analyzed 0 1 0 1
Measure Type: Number
Unit of Measure: percentage of participants
30 minutes post-treatment 0 0
60 minutes post-treatment 0 0
120 minutes post-treatment 100.0 100.0
240 minutes post-treatment 100.0 100.0
8.Secondary Outcome
Title Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the observed case dataset, a dataset without any imputation of missing data.
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Hide Arm/Group Description:
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.
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.
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.
All participants receiving either sumatriptan 25 mg or 50 mg
Overall Number of Participants Analyzed 70 33 41 74
Measure Type: Number
Unit of Measure: percentage of participants
12.9 12.1 14.6 13.5
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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Hide Arm/Group Description 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. 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. 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. All participants receiving either sumatriptan 25 mg or 50 mg
All-Cause Mortality
Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/33 (0.00%)   0/41 (0.00%)   0/74 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Sumatriptan 25 mg Sumatriptan 50 mg Sumatriptan Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/70 (7.14%)   2/33 (6.06%)   3/41 (7.32%)   5/74 (6.76%) 
General disorders         
Chest discomfort  1  0/70 (0.00%)  0/33 (0.00%)  3/41 (7.32%)  3/74 (4.05%) 
Investigations         
Blood creatine phosphokinase increased  1  4/70 (5.71%)  0/33 (0.00%)  0/41 (0.00%)  0/74 (0.00%) 
Nervous system disorders         
Somnolence  1  1/70 (1.43%)  2/33 (6.06%)  0/41 (0.00%)  2/74 (2.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00963937     History of Changes
Other Study ID Numbers: 111035
First Submitted: August 20, 2009
First Posted: August 24, 2009
Results First Submitted: July 28, 2011
Results First Posted: August 26, 2011
Last Update Posted: August 6, 2018