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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01332383

Enrollment

300

Registered

2011-04-11

Start date

2009-05-31

Completion date

2013-10-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Brief summary

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

Interventions

DRUGNaratriptan

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026