We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356603
First Posted: July 26, 2006
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Migraine Disorders Drug: Sumatriptan Succinate Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Imigran STATdose - Japan Clinical Experience Study for Self-injection

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 75
Actual Study Start Date: June 20, 2006
Study Completion Date: August 7, 2006
Primary Completion Date: August 7, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sumatriptan
Sumatriptan
Drug: Sumatriptan Succinate
Sumatriptan Succinate

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356603


Locations
Japan
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00356603     History of Changes
Other Study ID Numbers: STA106711
First Submitted: July 25, 2006
First Posted: July 26, 2006
Results First Submitted: June 22, 2017
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
Migraine
Sumatriptan Succinate Injection Kit
Cluster Headache
self-injection

Additional relevant MeSH terms:
Migraine Disorders
Cluster Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trigeminal Autonomic Cephalalgias
Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs