Migraine MedDRA version: 19.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Sumatriptan
Pharmaceutical Form: Tablet
INN or Proposed INN: SUMATRIPTAN
CAS Number: 103628-46-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
P
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is >10 years of age and 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, safety and tolerability of oral sumatriptan for the acute treatment of migraine in Japanese children ages 10 to 17 years.;Secondary Objective: Not applicable;Primary end point(s): Percentage of subjects who reported pain-relief (defined as at least 2 graded reduction in a 5-grade scale);Timepoint(s) of evaluation of this end point: 120 minutes post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy (Pain Relief) - Adverse events (AEs), Pregnancy, Laboratory assessments, Vital signs, Electrocardiogram (ECG), Physical examination;Timepoint(s) of evaluation of this end point: - 30, 60, and 240 minutes post-treatment | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed