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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01973205
Eligibility Criteria:
Inclusion criteria:
1. Male or female aged 18 years and over.
2. International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
3. History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
4. History of at least moderate migraine pain intensity, if left untreated.
5. History of frequently or always experiencing nausea with the migraine attack.
Exclusion criteria:
Subjects eligible for inclusion in this study must not fulfill any of the following criteria:
1. Headache symptoms which may be due to or aggravated by:
* Recent (within 6 months) head or neck trauma (e.g., whiplash)
* Head or neck pain secondary to an orthopedic abnormality
* Cluster headache
* Specific migraine variants (e.g., basilar-type artery migraine, opthalmoplegic migraine, hemiplegic migraine, migraine aura without headache)
* Other serious, non-migraine causes of headache (e.g., increased intracranial pressure, intracranial bleeding, meningitis, malignancy)
* Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)
2. History of vomiting during more than 20% of migraine attacks.
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01973205
Study Brief:
Protocol Section:
NCT01973205