Stage 1: Naltrexone/Acetaminophen
Combination
ALLOD-2Loading study record…
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* This two-stage clinical trial will assess a novel combination therapy for acute migraine. In Stage 1 (factorial), participants will receive the combination, each individual component, or placebo. In Stage 2 (dose-finding), they will test three doses of the combination. Before both stages, participants will complete a run-in period, documenting a migraine attack without study medication. They will then treat one migraine attack in each stage. * 4 visits * Requirements: Migraine Diagnosis. BMI below 34. Read, write, and speak English. No opioids, marijuana, benzodiazepines, or excessive alcohol.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-12-08
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
This study evaluating naltrexone-acetaminophen in the acute treatment of migraine.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Combination
ALLOD-2Naltrexone alone
Acetaminophen alone
Matching placebo
Combination high dose
ALLOD-2Combination medium dose
Combination low dose
ALLOD-2Matching Placebo
Eligibility
primary outcomes
Time frame: 2 hours after dosing
Freedom from pain is defined as the absence of headache pain from moderate or severe pain at baseline, without the use of rescue medication. The pain is measured on a 4-point scale, with 0 indicating no pain, 1 for mild pain, 2 for moderate pain, and 3 for severe pain.
Time frame: 2 hours after dosing
MBS freedom is defined as the absence of the identified Most Bothersome Symptom (MBS), which can be nausea, photophobia, or phonophobia. The MBS is measured on a binary scale, either absent or present.
secondary outcomes
Time frame: 2 hours after dosing
Pain relief is defined as a reduction in headache pain severity from moderate or severe to mild or no headache pain.
Time frame: 2 hours after dosing
Freedom from photophobia is defined as absence of photophobia
Time frame: 2 hours after dosing
Freedom from phonophobia is defined as absence of phonophobia
Time frame: 2 hours after dosing
Freedom from nausea is defined as absence of nausea
Time frame: 2 to 24 hours
Sustained pain relief is defined as the reduction of headache pain severity from moderate or severe intensity to mild without the use of rescue medication.
Time frame: 2 to 24 hours
Sustained pain freedom is defined as the absence of any headache pain of any intensity without the use of rescue medication.
Time frame: 2 hours after dosing
Functional disability refers to the inability to perform activities of daily living or work tasks to a normal level due to physical, mental, or sensory impairments. It is measured on a scale of 0 to 3, where 0 indicates normal function and 3 indicates the need for bedrest due to severe impairment.
Time frame: 24 hours after dosing
Functional disability refers to the inability to perform activities of daily living or work tasks to a normal level due to physical, mental, or sensory impairments. It is measured on a scale of 0 to 3, where 0 indicates normal function and 3 indicates the need for bedrest due to severe impairment.
Time frame: within 24 hours
Rescue medication use refers to the use of an additional medication to treat the current migraine.
Time frame: within 48 hours
Pain relapse refers to the reappearance of headache pain of any severity when the subject had been free of pain 2 hours after dosing.
other outcomes
Time frame: Baseline (Randomization Visit) to 2 hours after dosing
The Hamilton Anxiety Rating Scale is a validated assessment tool for measuring anxiety symptoms. The scale consists of fourteen items designed to assess the severity of anxiety on a scale of zero to four, with four being the most severe.
Time frame: Baseline (Randomization Visit) to 24 hours after dosing
The Hamilton Anxiety Rating Scale is a validated assessment tool for measuring anxiety symptoms. The scale consists of fourteen items designed to assess the severity of anxiety on a scale of zero to four, with four being the most severe.
Time frame: 2 hours after dosing
Self-reported overall sense of wellbeing (physical and emotional) is a subjective measurement that reflects an individual's perception of their physical and emotional health. It is typically assessed on a 4-point scale, ranging from 0 (Poor) to 3 (Superb), with 1 (Okay) and 2 (Good) representing intermediate levels of wellbeing. This measurement considers factors such as physical pain, positive emotions, life satisfaction, stress management, and the absence of negative emotions like depression and anxiety.
Time frame: 2 hours after dosing
Self-reported hurt feelings on a 4-point scale: (0=Not at all, 1=Slightly, 2=Moderate, 3=Extremely).
Time frame: 2 hours after dosing
Self-reported tense feelings on a 4-point scale: (0=Not at all, 1=Slightly, 2=Moderate, 3=Extremely).
Publications
No exact PMID-linked public article is currently readable locally.