NCT01376193

Brief Summary

The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 20, 2013

Status Verified

May 1, 2013

Enrollment Period

2.5 years

First QC Date

June 9, 2011

Last Update Submit

May 16, 2013

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • The number of incidence of adverse events in subjects with migraine headache

    2 months

Secondary Outcomes (3)

  • Occurrence of cardiovascular-related adverse events

    2 months

  • Occurrence of cerebrovascular disorder

    2 months

  • Occurrence of serotonin syndrome

    2 months

Study Arms (1)

Subjects prescribed naratriptan tablets

Subjects with migraine headache prescribed naratriptan tablets during study period

Drug: Naratriptan

Interventions

NaratriptanDRUG

Collection of safety data

Subjects prescribed naratriptan tablets

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese subjects with migraine headache

You may qualify if:

  • Subjects with migraine headache
  • Must use naratriptan tablets for the first time

You may not qualify if:

  • Subjects with hypersensitivity to naratriptan
  • Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
  • Subjects with history of peripheral vascular disorder
  • Subjects with history of cerebrovascular disorder or transient ischemic attacks
  • Subjects with uncontrolled high-blood pressure
  • Subjects with severe hepatic function disorder or renal function disorder
  • Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Takao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.

    BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

naratriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 20, 2011

Study Start

April 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 20, 2013

Record last verified: 2013-05