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The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination | Clinical Trials | Clareo Health

COMPLETEDPHASE2

The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination

Randomized, Double-Blind, Study to Assess Low-Dose Naltrexone and Acetaminophen Combination in the Prevention of Episodic Migraine in Adults

NCT03194555•Allodynic Therapeutics, Inc

View on ClinicalTrials.gov

Summary

The Preventive Treatment of Migraine with Low-Dose Naltrexone and Acetaminophen Combination: A Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient is a male or a female 18 years of age or older.
•2. History of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version) for at least one-year with onset of migraine prior to 50 years of age.
•3. Migraine-associated nausea with ≥half of migraine attacks.
•4. 5-8 migraine/probable migraine headache days on average per month in the three months prior to Visit 1 and during the Baseline Period.
•5. The patient agrees to refrain from taking opiate medications from Visit 1 to 7 days after the last dose of the study drug.
•6. The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA.
•7. The patient has been taking a stable dose of a medication with migraine prevention potential for at least 3 month prior to the screening visit and agrees to not start, stop, or change dosage of any medication with migraine prevention potential during the study period. (E.g., beta-blockers, calcium channel blockers, tricyclic antidepressants, anticonvulsants, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), magnesium or riboflavin supplements at high doses, herbal preparations (e.g. feverfew or St. john's wort)), Botulinum toxin must be discontinued one year prior to Visit 1.
•8. The patient agrees to forgo any elective surgery for the duration of the study.
•9. The female patient who is premenopausal or postmenopausal less than 1 year, or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative urine pregnancy test, be non-lactating, and commit to using 2 methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study drug (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). Male patients must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after the study.

Exclusion Criteria

•1. Usage of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) ≥15 days/month, or ergotamine and triptans \>10 days/month, or opioids and barbiturates \>2 days/month in the 3 months prior to Visit 1 or during the Baseline Period.
•2. Tension-type-like, and/or migraine-like headache on ≥15 days per month in the 3 months prior to Visit 1 or during the Baseline Period. Diagnosis of chronic migraine, cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
•3. Regular use of the following medications for any reason: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), antipsychotic drugs, monoamine oxidase inhibitors, benzodiazepines, sleep medications, muscle relaxants, anti-emetic medications, blood thinning medications (e.g., warfarin or heparin), cannabinoids, or botulinum toxin to head and neck regions. Low-dose aspirin for cardiovascular disease prophylaxis is permitted.
•4. Confounding painful conditions, (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome, etc.).
•5. Diagnosis of any concurrent medical or psychiatric condition; this includes, chronic unstable debilitating diseases such as Parkinson's disease, multiple sclerosis, cancer, significant renal impairment, significant hepatic impairment, etc.
•6. The patient has a history or diagnosis of moderate-to-severe hepatic or renal impairment (\>2 × the upper limit of normal \[ULN\] for alanine transaminase or aspartate transaminase. ≥1.5 × ULN for alkaline Phosphatase, bilirubin, BUN, or creatinine). (Patients with elevated bilirubin level due to Gilbert's syndrome are allowed).
•7. The patient has a history within the previous 5 years of abuse of any drug, prescription, illicit, or alcohol.
•8. The Female patient is pregnant, actively trying to become 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-allergy to any of the components of the investigational drug.
•10. Participation in another study with an investigational drug within 30 days before Visit 1 or during the study.
+2 more criteria

Locations (1)

Annette Toledano, M.D.

North Miami, Florida, United States

Key Dates

Start Date

August 25, 2017

Primary Completion Date

July 26, 2018

Completion Date

July 28, 2018

Last Updated

April 10, 2024

Enrollment

ACTUAL participants

Conditions

Migraine With or Without Aura

Interventions

Low-Dose Naltrexone and Acetaminophen Combination

DRUG

Placebo

DRUG

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

NCT03061734

Migraine With or Without Aura

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COMPLETEDPHASE3

Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

NCT01986088

Migraine With or Without Aura

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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