Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

Condition(s) targeted: Migraine Disorders

Intervention: Naratriptan (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

Study design: Time Perspective: Prospective

Primary outcome: The number of incidence of adverse events in subjects with migraine headache

Secondary outcome:

Occurrence of cardiovascular-related adverse events

Occurrence of cerebrovascular disorder

Occurrence of serotonin syndrome

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Related publications:

Takao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.

Starting date: April 2009
Last updated: May 16, 2013