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

Migraine Disorders Clinical Trial

Official title:

Imigran STATdose - Japan Clinical Experience Study for Self-injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356603
• Other study ID #: STA106711
• Status: Completed
• Phase: Phase 3
• Start date: June 20, 2006
• Est. completion date: August 7, 2006

Study information

• Verified date: August 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 7, 2006
• Est. primary completion date: August 7, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Migraine Disorders

Intervention

Drug:
• Sumatriptan Succinate
Sumatriptan Succinate

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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