Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Naratriptan

• Study Type: Observational
• Enrollment (Actual): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Japanese subjects with migraine headache

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects prescribed naratriptan tablets; Subjects with migraine headache prescribed naratriptan tablets during study period	Drug: Naratriptan; Collection of safety data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of incidence of adverse events in subjects with migraine headache	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of cardiovascular-related adverse events	Occurrence of cardiovascular-related adverse events is investigated throughout study period	2 months
Occurrence of cerebrovascular disorder	Occurrence of cerebrovascular disorder is investigated throughout study period	2 months
Occurrence of serotonin syndrome	Occurrence of serotonin syndrome is investigated throughout study period	2 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (Estimate): June 20, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2013
• Last Update Submitted That Met QC Criteria: May 16, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Naratriptan
• Other Study ID Numbers: 112924