Naltrexone and Acetaminophen Combination and Its Components in Adult Acute Migraine (AT-06)

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compares the efficacy of naltrexone/acetaminophen combination and each component versus placebo in the treatment of acute migraine and co-morbid anxiety in adults

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allodynic Therapeutics, LLC
• Treatments: Acetaminophen; Naltrexone

Criteria

Inclusion Criteria:

1. Male or female ages 18 to 75 years, inclusive

2. At least 1-year of history of migraine with or without aura as defined by the International Classification of Headache Disorders 3rd edition (ICHD-3)

3. Migraine onset before age 50 years

4. Able to refrain from using any opioid medications (including methadone and buprenorphine) during the study and 7 days after taking the study medication

Exclusion Criteria:

1. A woman who is pregnant, nursing, or planning a pregnancy

2. Using medications to treat headaches or any other pain syndrome ≥10 days per month in any of the 3 months prior to screening (including APAP, NSAIDs, triptans, ergotamine, opioids, or combination analgesics)

3. Using any opioids, barbiturate-containing medications, muscle relaxants, benzodiazepines, or marijuana within 6 months prior to screening

4. Having symptoms consistent with chronic migraine, hemiplegic migraine, retinal migraine, trigeminal autonomic cephalgia, cranial neuropathy, or new persistent daily headache

5. Having body mass index > 33 kg/m2

6. Having a history of cardiovascular or cerebrovascular disease including the following:

ischemic heart disease, unstable angina, myocardial infarction, transient ischemic attack, Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke, or transient ischemic attack (TIA), heart failure class III or IV; atrial fibrillation, 2nd, or 3rd-degree atrioventricular block within 6 months prior to screening

7. Having Uncontrolled hypertension or diabetes. Major depression, schizophrenia, dementia, epilepsy, major neurological disorders, or pain syndromes

8. Having a history of gastric or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.) or a disease that causes malabsorption. Hepatic disease or suspected infection, (hepatitis B or C, or cancer). Also, any current use of prescription anti-coagulant (Pradaxa, Coumadin, Eliquis, Xarelto)

9. Having significant hematologic, endocrine, pulmonary, renal, hepatic, or gastrointestinal disease; history of malignancy

10. Having a history of alcohol or drug abuse within the previous 12 months, current cannabis use, or a positive urine drug test at the Screening Visit

11. having clinically significant ECG abnormalities