Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Cluster Headache
Intervention: Sumatriptan Succinate
Intervention description: Sumatriptan Succinate
Intervention MeSH terms: Sumatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Sumatriptan Succinate Injection Kit; Cluster Headache; self-injection

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.
    

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