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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT01090050
Eligibility Criteria:
Inclusion Criteria:
Subject
* Is male or female, in otherwise good health, 18 to 65 years of age.
* Has history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society for at least 3 months prior to enrollment.
* Has onset of migraine before age 50.
* Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache).
* Has stable history of headache for at least 3 months prior to screening.
* Is not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
* If female of childbearing potential, has a negative urine pregnancy test at Visit 1 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator.
* Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug (a minimum of 7 days); or,
* Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,
* Sterilization of male partner; or,
* Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or,
* Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or,
* Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.
Exclusion Criteria:
Subject
* Is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
* Is pregnant, actively trying to become pregnant, or breast-feeding.
* Has experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine.
* Has a history of Medication Overuse Headache in the 3 months prior to study enrollment or during the Baseline Period.
* Has abused, in the opinion of the Investigator, any of the following drugs, currently or within the past 1 year: opioids, alcohol, barbiturates, benzodiazepine, cocaine
* Has an unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.
* Suffers from cardiovascular disease (ischemic heart disease, including angina pectoris, myocardial infarction, documented silent ischemia, or with Prinzmetal's angina); has symptoms of ischemic heart disease; have uncontrolled hypertension; has electrocardiogram (ECG) results outside normal limits for clinically stable patients as judged by the investigator.
* Has a history of asthma, allergy, or nasal polyps developing for the first time over the age of 40.
* Has a history of peptic ulcer disease requiring therapeutic intervention in the year prior to study enrollment.
* Has a history of bleeding peptic ulcer disease or perforation of the stomach or intestine.
* Has a history of bleeding disorder.
* Has history of Non-steroidal anti-inflammatory drug (NSAID) induced gastritis, esophagitis, or duodenitis.
* Suffers from a serious illness, or an unstable medical condition that could require hospitalization, or could increase the risk of adverse events.
* Has significant (as determined by the investigator) cardiovascular risk factors that may include uncontrolled high blood pressure, post-menopausal women, males over 40 years old, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family history of cardiovascular disease in a 1st degree relative.
* Has a psychiatric condition, in the opinion of the investigator that may affect the interpretation of efficacy and safety data or contraindicates the subject's participation in the study.
* Has hypersensitivity, intolerance, or contraindication to the use of sumatriptan, any of its components, or any other 5-hydroxytryptamine1 (5-HT1) agonist.
* Has a hypersensitivity, intolerance, or contraindication to the use of naproxen, any of its components, or any other non-steroidal anti-inflammatory drug including aspirin and cyclooxygenase-2 (COX-2) inhibiting agents.
* Is currently taking a migraine prophylactic medication containing an ergotamine or ergot derivative such as dihydroergotamine (DHE) or methysergide.
* Has taken, or plans to take, a monoamine oxidase inhibitor (MAOI) including herbal preparations containing St. John's wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.
* Has received any investigational agents within 30 days prior to Visit 1.
* Plans to participate in another clinical study at any time during this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01090050
Study Brief:
Protocol Section:
NCT01090050