CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Low-Dose Naltrexone and Acetaminophen Combination +1 moredrug
Likely dose
Low-dose naltrexone and acetaminophen combination, twice dailyAI-extracted
Key inclusion· 6
  • ✓Age 18 years or older
  • ✓Migraine with or without aura diagnosed per ICHD-3rd edition, onset before age 50, duration ≥1 year
  • ✓Migraine-associated nausea in ≥50% of migraine attacks
  • ✓5–8 migraine/probable migraine headache days per month averaged over 3 months before Visit 1 and during Baseline Period
Key exclusion· 9
  • ✕Acetaminophen/NSAIDs ≥15 days/month, ergotamine/triptans >10 days/month, or opioids/barbiturates >2 days/month in 3 months prior to Visit 1 or during Baseline Period
  • ✕Chronic migraine, cluster headache, or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic)
  • ✕Tension-type-like and/or migraine-like headache on ≥15 days per month in 3 months prior to Visit 1 or during Baseline Period
  • ✕Regular use of acetaminophen, NSAIDs, antipsychotics, MAOIs, benzodiazepines, sleep medications, muscle relaxants, antiemetics, blood thinners, or cannabinoids (low-dose aspirin for cardiovascular prophylaxis allowed)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03194555
NCT03194555Phase 2Completed
CompareCT.gov

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

Allodynic Therapeutics, Inc·interventional·Posted Jun 21, 2017·Updated Apr 10, 2024

In Brief

A Phase 2 clinical trial evaluating Low-Dose Naltrexone and Acetaminophen Combination and Placebo for Migraine With or Without Aura. Completed, enrolled 12 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine With or Without Aura
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartAug 25, 2017
Primary CompletionJul 26, 2018
Study CompletionJul 28, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.0 years ago

Interventions

Low-Dose Naltrexone and Acetaminophen Combinationdrug

Twice daily

Placebodrug

Twice daily