Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine

Exclusion Criteria

• •1. The patient in the opinion of the investigator, may have medication-overuse headache pain (as defined by ICHD - 3 beta criteria for medication-overuse headache), (analgesic, opioid, ergotamine or triptan overuse) during the 3 months preceding screening.
• •2. The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine).
• •3. History of cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
• •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, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), or Botox).
• •5. Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
• •6. A history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.
• •7. 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.
• •8. Use of opiates or barbiturates more than 3 days per month.
• •9. Known-hypersensitivity reaction to any of the components of the investigational drug.
• •10. Consumption of analgesic medication for other conditions on a regular basis, (nonsteroidal anti-inflammatory drugs, or acetaminophen, or muscle relaxants).
• •11. Use of emergency care treatment more than 3 times in the previous 6 months.
• •12. Participation in another study with an investigational drug within 30 days prior to randomization and/or a plan to participate during the study.