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

NCT01332383 — Completed, 300 participants, GlaxoSmithKline

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

Registry	NCT01332383
Status	Completed
Study type	Observational
Enrollment	300 (Actual)
Sponsor	GlaxoSmithKline (Industry)
Conditions	Migraine Disorders
Interventions	Naratriptan (Drug)
Dates	start 2009-05-01, primary completion 2013-10-01, completion 2013-10-01, first posted 2011-04-11, last updated 2015-08-13

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Patients prescribed AMERGE		Drug: Naratriptan	Patients with migraine disorders prescribed AMERGE during study period

Naratriptan (Drug)

+Outcome measures

Primary outcomes

The number of adverse drug reactions and serious adverse events [6 months]

+Eligibility

Sex: All

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

+Investigators

GSK Clinical Trials, Study director, GlaxoSmithKline