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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01332383
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : August 13, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Migraine Disorders Drug: Naratriptan

Study Type : Observational
Actual Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for AMERGE Tablet (Long-term)
Study Start Date : May 2009
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. The number of adverse drug reactions and serious adverse events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with migraine headache who are naive to AMERGE

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332383

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332383     History of Changes
Other Study ID Numbers: 112925
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs