Last updated: 11/04/2018 12:30:18

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

GSK study ID
STA106711
See study documents
Clinicaltrials.gov ID
NCT00356603
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Imigran STATdose - Japan clinical experience study for self-injection
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Percentage of participants with headache Relief at 60 minutes post dose(Migraine) or 30 minutes Post dose(Cluster Headache)

Timeframe: 30 minutes or 60 Minutes after each administration

Secondary outcomes:

Number of participants with subject-rated acceptability of the sumatriptan 3mg kit product

Timeframe: Up to 2 months

Percentage of participants with investigator/sub investigator-rated successful self-injection rate

Timeframe: Up to 2 months

Interventions:
  • Drug: Sumatriptan Succinate
    • Enrollment:
    75
    Primary completion date:
    2006-07-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Migraine Disorders
    Product
    sumatriptan
    Collaborators
    Not applicable
    Study date(s)
    June 2006 to August 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II)
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 105-7103
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Aichi, Japan, 450-0002
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hyogo, Japan, 663-8204
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kyoto, Japan, 600-8811
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-07-08
    Actual study completion date
    2006-07-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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