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OpenTrials
Completed

NCT Number: NCT01332383

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

Completed

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naratriptan

Drug

Primary outcomes

  1. The number of adverse drug reactions and serious adverse events

    Time frame: 6 months

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2011
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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