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

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Sumatriptan Succinate
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Migraine, Sumatriptan Succinate Injection Kit, Cluster Headache, self-injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sumatriptan

Arm Description

Sumatriptan

Outcomes

Primary Outcome Measures

Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
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.

Secondary Outcome Measures

Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
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.
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
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.

Full Information

First Posted
July 25, 2006
Last Updated
August 30, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00356603
Brief Title
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Official Title
Imigran STATdose - Japan Clinical Experience Study for Self-injection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 20, 2006 (Actual)
Primary Completion Date
August 7, 2006 (Actual)
Study Completion Date
August 7, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Migraine, Sumatriptan Succinate Injection Kit, Cluster Headache, self-injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sumatriptan
Arm Type
Experimental
Arm Description
Sumatriptan
Intervention Type
Drug
Intervention Name(s)
Sumatriptan Succinate
Intervention Description
Sumatriptan Succinate
Primary Outcome Measure Information:
Title
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
Description
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.
Time Frame
30 minutes or 60 Minutes after each administration
Secondary Outcome Measure Information:
Title
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
Description
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.
Time Frame
Up to 2 months
Title
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
Description
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.
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
450-0002
Country
Japan
Facility Name
GSK Investigational Site
City
Hyogo
ZIP/Postal Code
663-8204
Country
Japan
Facility Name
GSK Investigational Site
City
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
105-7103
Country
Japan

12. IPD Sharing Statement

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

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