The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination (NCT03194555) | Clinical Trial Compass
CompletedPhase 2
The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination
United States12 participantsStarted 2017-08-25
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The patient is a male or a female 18 years of age or older.
✓. 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.
✓. Migraine-associated nausea with ≥half of migraine attacks.
✓. 5-8 migraine/probable migraine headache days on average per month in the three months prior to Visit 1 and during the Baseline Period.
✓. The patient agrees to refrain from taking opiate medications from Visit 1 to 7 days after the last dose of the study drug.
✓. 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.
✓. 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.
✓. The patient agrees to forgo any elective surgery for the duration of the study.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in Monthly Migraine Days (MMD) From Baseline to the Last 28 Days of Treatment Period.
Timeframe: From the 28-day baseline period to the last 28 days of the 84-days double-blinded treatment period.
✕. 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).
✕. 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.
✕. 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.
✕. 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).
✕. The patient has a history within the previous 5 years of abuse of any drug, prescription, illicit, or alcohol.
✕. 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.