Migraine Disorders
Conditions
Brief summary
The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.
Interventions
DRUGNaratriptan
Collection of safety data
Sponsors
GlaxoSmithKline
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with migraine headache * Must use naratriptan tablets for the first time
Exclusion criteria
* Subjects with hypersensitivity to naratriptan * Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina * Subjects with history of peripheral vascular disorder * Subjects with history of cerebrovascular disorder or transient ischemic attacks * Subjects with uncontrolled high-blood pressure * Subjects with severe hepatic function disorder or renal function disorder * Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of incidence of adverse events in subjects with migraine headache | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of cardiovascular-related adverse events | 2 months | Occurrence of cardiovascular-related adverse events is investigated throughout study period |
| Occurrence of cerebrovascular disorder | 2 months | Occurrence of cerebrovascular disorder is investigated throughout study period |
| Occurrence of serotonin syndrome | 2 months | Occurrence of serotonin syndrome is investigated throughout study period |
Outcome results
None listed