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

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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with migraine headache who are naive to AMERGE

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients prescribed AMERGE; Patients with migraine disorders prescribed AMERGE during study period	Drug: Naratriptan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of adverse drug reactions and serious adverse events	6 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (ESTIMATE): April 11, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

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: 112925