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Special Drug Use Investigation for AMERGE® Tablet (Long-term)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

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


To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting

Clinical Details

Official title: Special Drug Use Investigation for AMERGE Tablet (Long-term)

Study design: Time Perspective: Prospective

Primary outcome: The number of adverse drug reactions and serious adverse events


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


Inclusion Criteria:

- Must use AMERGE for the first time

Exclusion Criteria:

- Patients with hypersensitivity to naratriptan or any of the components.

- Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac

or angina inversa

- Patients with history of cerebral vascular disturbance or transient ischaemic attack

- Patients with peripheral vascular syndromes

- Patients with uncontrolled hypertension

- Patients with severe renal or hepatic impairment

- Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or

ergot-type medication

Locations and Contacts

Additional Information

Starting date: May 2009
Last updated: August 10, 2015

Page last updated: August 20, 2015

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