Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan

August 30, 2018 updated by: GlaxoSmithKline

Imigran STATdose - Japan Clinical Experience Study for Self-injection

This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, 450-0002
        • GSK Investigational Site
      • Hyogo, Japan, 663-8204
        • GSK Investigational Site
      • Kyoto, Japan, 600-8811
        • GSK Investigational Site
      • Tokyo, Japan, 105-7103
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II)
  • History of migraine or cluster headache persisting for at least 6 months
  • Migraine: One to 6 attacks of moderate or severer headaches per month during the 2 months prior to enrollment
  • Cluster Headache: Each attack persisting for at least 45 minutes
  • Written informed consent obtained from the patient. When a patient is a minor, written informed consent from his/her proxy consenter (e.g., person with parental authority) will also be required.

Exclusion criteria:

  • History of hypersensitivity to any of the ingredients of 5-HT1B/1D receptor antagonists (e.g., triptans) or serious AE due to treatment with these drugs
  • History of serious adverse event attributable to treatment with Imigran® Injection 3
  • History of myocardial infarction, current or previous history of ischemic heart disease or its symptoms/signs, or current history of atypical variant angina (coronary arteriospasm)
  • Previous history of cerebrovascular disorder or transient cerebral ischemic attack
  • Current or previous history of peripheral angiopathy (including Raynaud's syndrome)
  • Systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >95 mmHg at the start of treatment period
  • Current familial hemiplegic migraine, basilar migraine, or sporadic hemiplegic migraine
  • Current abuse of ergotamine- or dihydroergotamine-containing preparations or triptans
  • Pregnant women, lactating mothers, women who may be pregnant, or women of childbearing potential using no appropriate contraceptive measures.
  • Epilepsy or organic cerebral disorder which may lead to convulsion
  • Previous history of hypersensitivity to sulfonamides
  • Known drug allergy or idiosyncrasies
  • Known drug dependency or alcoholism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sumatriptan
Drug: Sumatriptan Succinate
Sumatriptan Succinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
Time Frame: 30 minutes or 60 Minutes after each administration
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
30 minutes or 60 Minutes after each administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Time Frame: Up to 2 months
The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was "Was the kit product easy to use?", question 2 was "Do you want to use the kit product in the future?" and question 3 was "Do you consider that the kit product is necessary for the treatment of your illness?". The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented.
Up to 2 months
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
Time Frame: Up to 2 months
The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented.
Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2006

Primary Completion (Actual)

August 7, 2006

Study Completion (Actual)

August 7, 2006

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Actual)

September 4, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STA106711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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