Phase 3
N=178
Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents
Migraine Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00963937 ↗Enrolled (actual)
178
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment — 38.6; 31.1 percentage of participants — p=0.345
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sumatriptan 25 mg (Drug); Sumatriptan 50 mg (Drug); Placebo (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment |
38.6; 31.1 | 0.345 |
| SECONDARY Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment |
4.3; 0; 9.8; 5.4; 18.6; 9.1 | — |
| SECONDARY Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment |
2.9; 0; 2.4; 1.4; 12.9; 3.0 | — |
| SECONDARY Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment |
16.7; 13.3; 15.4; 14.3; 44.4; 26.7 | — |
| SECONDARY Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment |
22.7; 50.0; 12.5; 30.0; 45.5; 57.1 | — |
| SECONDARY Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment |
47.6; 40.0; 12.5; 27.8; 66.7; 40.0 | — |
| SECONDARY Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment |
0; 0; 0; 0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment |
12.9; 12.1; 14.6; 13.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject is >10 years of age and 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Exclusion Criteria
- Subject is < 30 kg.
- Subject has 15 or more headache days per month in total (migraine, probable migraine, or tension-type). Subject has retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), hemiplegic (ICHD-II 1.2.4 or 1.2.5), or Ophthalmoplegic migraine (ICHD-II 13.17). Subject has secondary headaches.
- Subject has a history of cerebrovascular disease or ischemic cerebrovascular disease.
- Subject has a history of myocardial infarction.
- Subject has uncontrolled hypertension.
- Subject has symptoms or signs of ischemic cardiac syndromes.
- Subject has variant angina.
- Subject has evidence of a peripheral vascular syndrome.
- Subject has evidence or history of epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control.
- Subject has a history of impaired hepatic or renal function that, in the investigator (or subinvestigator)'s opinion, contraindicates participation in this study. Subject has unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice). Subject has cirrhosis. Subject has known biliary abnormalities (with the exception of Gilberts's syndrome or asymptomatic gallstones).
- Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan (including all sumatriptan preparations) or sulfonamide compounds.
- Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis.
- Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI) anytime within the two weeks prior to entry into the study.
- Subject has evidence of psychotropic, alcohol, or substance abuse within the last year.
- Subject has participated in any investigational drug trial within the previous 3 months or plans to participate in another study at any time during this study.
- Subject has any concurrent medical or psychiatric condition which, in the investigator (or subinvestigator)'s judgment, contraindicates participation in this clinical trial.
Data sourced from ClinicalTrials.gov (NCT00963937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.