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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00894556
Eligibility Criteria:
Inclusion Criteria:
* Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
* Patient generally does not respond to treatment with sumatriptan
* Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
* Patient is able to complete paper diary
Exclusion Criteria:
* Patient is pregnant or breast feeding or excepts to become pregnant during the study
* Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
* Patient has basilar or hemiplegic migraines
* Patient is unable to distinguish between migraine attacks from other types of headaches
* Patient has more than 15 headache-days per month
* Patient was greater than 50 years old at age of migraine onset
* Patient has failed to respond to 3 or more triptans
* Patient has a repeated history of failing to respond to or tolerate rizatriptan
* Patient uses opioids as primary migraine therapy
* Patient uses daily opioids
* Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
* Patient has uncontrolled hypertension
* Patient has a history of neoplastic disease
* Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
* Patient has a history of drug or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00894556
Study Brief:
Protocol Section:
NCT00894556