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

NCT00356603 | Completed Phase 3 Results

• 1 other identifier: STA106711
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 4

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.

Conditions

Migraine Disorders

Keywords

Migraine; Sumatriptan Succinate Injection Kit; Cluster Headache; self-injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product

  Up to 2 months

• Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate

  Up to 2 months

Study Arms (1)

Sumatriptan

EXPERIMENTAL

Sumatriptan

Drug: Sumatriptan Succinate

Interventions

Sumatriptan Succinate DRUG

Sumatriptan Succinate

Sumatriptan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Aichi, 450-0002, Japan

Location

GSK Investigational Site

Hyōgo, 663-8204, Japan

Location

GSK Investigational Site

Kyoto, 600-8811, Japan

Location

GSK Investigational Site

Tokyo, 105-7103, Japan

Location

MeSH Terms

Conditions

Migraine Disorders; Cluster Headache

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Autonomic Cephalalgias

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 26, 2006
• Study Start: June 20, 2006
• Primary Completion: August 7, 2006
• Study Completion: August 7, 2006
• Last Updated: September 4, 2018
• Results First Posted: November 20, 2017

Record last verified: 2018-08

Locations

JP (4)