Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00356603
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00356603
Study Brief:
Protocol Section:
NCT00356603