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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT01450995
Eligibility Criteria:
Inclusion Criteria:
A subject will be eligible for inclusion in this study if all of the following criteria apply:
1. Subject is male or female.
2. Subject is age 18 to 65.
3. A female is eligible to enter and participate in this study if she is not breast feeding and is of: non-childbearing potential (i.e. physiologically incapable of becoming pregnant) or child-bearing potential, has a negative urine pregnancy test at screening and agrees to use an acceptable method of contraception during the course of the study or, Female sterilization; or, Sterilization of male partner; or Implants of levonorgestrel; or Injectable progestogen; or Oral contraceptive (combined or progestogen only); or Any intrauterine device (IUD) meet this criterion; or Double barrier method; or Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year
4. Subject has a diagnosis of migraine and meets IHS criteria for migraine with or without aura (1.1) or migraine with aura (1.2)
5. Subject has at least a 1-year history of migraine with 2-6 migraines per month in the three months prior to screening
6. Subject typically experiences moderate to severe migraine pain preceded by an identifiable mild pain phase.
7. Subject is able to read, understand and complete diaries, subject questionnaires and the instructions for the study.
8. Subject is able and willing to give written informed consent to participate in the study.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina, or signs/symptoms consistent with any of the above.
2. Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome.
3. Subject has cardiac arrhythmias requiring medication or a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
4. Subject has a history of cerebrovascular pathology including stroke.
5. Subject has a history of congenital heart disease.
6. Subject has uncontrolled hypertension at screening (sitting (\>140 mmHg systolic pressure or \>90mmHg diastolic pressure).
7. Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
8. Subject has significant peripheral vascular disease
9. Subject is currently taking any anti-coagulant (e.g., Coumadin®).
10. Subject has a history of inflammatory bowel disease.
11. Subject has a history of any bleeding disorder.
12. Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
13. Subject is taking any antiplatelet agent (except low-dose aspiring ≤ 325 mg/day for cardioprotective reasons).
14. Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
15. Subject has a history of epilepsy.
16. Subject has basilar migraine, hemiplegic migraine or cluster headache.
17. Subject has impaired renal, hepatic, of any gastrointestinal surgery, gastrointestinal obstruction or perforation.
18. Subject who is currently taking monoamine oxidase inhibitor drugs (MAOIs), or has taken any MAOI within 2 weeks prior to screening.
19. Subject is pregnant, actively trying to become pregnant or breast-feeding.
20. Subject has ≥ 15 headache days in any of the three previous months prior to screening.
21. Subject is of childbearing potential and not using adequate contraceptive measures.
22. Subject has evidence of a rebound headache pattern caused by ergotamines or analgesics in the past three months.
23. Subject has evidence of alcohol or substance abuse within the last year, which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results.
24. Subject has any concurrent medical condition which may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial.
25. Subject has participated in an investigational drug trial within the previous four weeks, or plans to participate in another study at any time during this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01450995
Study Brief:
Protocol Section:
NCT01450995