Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea

Exclusion Criteria

• •1. The patient in the opinion of the investigator may have medication-overuse headaches (as defined by ICHD - 3 beta criteria for medication-overuse headache) during the preceding 3 months.
• •2. The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine) during the preceding 3 months.
• •3. History of cluster headaches or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic).
• •4. Initiation or change in medications with possible migraine prophylactic effects during 3 months before inclusion into the trial (E.g., calcium channel blockers, tricyclic antidepressants, beta-blockers, or Botox).
• •5. Use of opiates or barbiturates more than 3 days per month.
• •6. Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
• •7. The patient has a history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.
• •8. The Female patient is pregnant or breast-feeding. The Male patient is not practicing 2 different methods of birth control with their partner during the study, and for 28 days after the investigational drug last dose or will not remain abstinent during the study, and for 28 days after the last dose.
• •9. The patient has known-hypersensitivity reaction to any of the components of the investigational drug.
• •10. Consumption of analgesic medication or muscle relaxants (including all benzodiazepines) for other conditions on a regular basis.
• •11. The patient has used emergency care treatment more than 3 times in the previous 6 months.
• •12. The patient has participated in another study with an investigational drug within 30 days prior to randomization and/or plan to participate during the study.
• •13. The patient has a history of congenital heart disease, cardiac arrhythmias, or cardiovascular disease, e.g., ischemic heart disease (e.g., stable angina pectoris, unstable angina, vasospastic angina, myocardial infarction or silent myocardial ischemia), cerebrovascular syndromes (e.g., strokes of any type or transient ischemic attacks), peripheral vascular disease, ischemic bowel disease, or Raynaud syndrome.
• •14. Uncontrolled hypertension (sitting \>160 mmHg systolic pressure or \>95mmHg diastolic pressure).
• •15. The patient, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
• •16. History of epilepsy. Allergy to sulfonamides.
• •17. Consumption of monoamine oxidase inhibitor (MAOI) drug, tricyclic antidepressant, selective serotonin reuptake inhibitor (SSRI) or Serotonin Noradrenaline Reuptake Inhibitor (SNRI).