F Hormonal contraceptives for at least 3 months prior to visit 1

F. Hormonal contraceptives for at least 3 months prior to visit 1 and throughout the study. 9. Had ≥6 migraine treatment days in 1 month (baseline) prior to

visit 2. Exclusion Criteria: 1. Unable to understand the study requirements, the informed consent, or complete headache records as required per protocol. 2. Pregnant, actively trying to become pregnant, or breast-feeding. 3. Experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine. 4. History of medication overuse headache in the 3 months prior to study enrollment or during the MG-132 manufacturer baseline phase. 6. Abuse, in the opinion of the investigator, of any

of the following drugs, currently or within the past 1 year: 1. Opioids 2. Alcohol 3. Barbiturates 4. Benzodiazepine 5. Cocaine 7. History of significantly learn more impaired hepatic or renal function that, in the investigator’s opinion, contraindicates participation in this study. 8. Unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure. 9. History of asthma and/or nasal polyps. 10. History of peptic ulcer disease requiring therapeutic intervention in the year prior to study enrollment. 11. Evidence or history of any gastrointestinal (GI) surgery or GI ulceration or perforation of the stomach or intestine in the past 6 months, gastrointestinal bleeding in the past year or evidence or history of inflammatory bowel disease or history of any other bleeding disorder, or has taken or plans to take any anticoagulant or any antiplatelet agent within the 2 weeks prior to screening through 48 hours post final study treatment.

12. History of nonsteroidal anti-inflammatory drug induced gastritis, esophagitis, or duodenitis. 15. Has in the opinion of Rolziracetam the investigator a significant cardiovascular or cerebrovascular disease or risk profile. 16. Has a psychiatric condition, in the opinion of the investigator, which may affect the interpretation of efficacy and safety data or contraindicates the subject’s participation in the study. 18. Has hypersensitivity, intolerance, or contraindication to the use of sumatriptan, any of its components, or any other 5-Ht1 agonist or naproxen sodium or other NSAIDs. 19. Is currently taking a migraine prophylactic medication containing an ergotamine or ergot derivative such as dihydroergotamine (DHE) or methysergide. 20. 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. 21.

Leave a Reply

Your email address will not be published. Required fields are marked *

*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>