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

Study Overview
=================
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.

Official Title
-----------------
Imigran STATdose - Japan Clinical Experience Study for Self-injection

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: Sumatriptan Succinate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sumatriptan<br>Sumatriptan | Drug: Sumatriptan Succinate<br>* Sumatriptan Succinate<br>|

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) | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Sumatriptan Succinate Injection Kit, Cluster Headache, self-injection