This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine.
The study consists of a screening visit, outpatient treatment of a moderate or severe migraine attack with a single dose of the study drug within 8 weeks, and End-of-Study Visit 2-7 days after dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Treat a single Qualified Migraine attack.
One capsule contains Sumatriptan 100 mg and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.
One capsule contains a sham for component A and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.
Annette C. Toledano, M.D.
North Miami, Florida, United States
The proportion of patients having no headache pain at 2 hours.
Measured by asking the patients to self-report the current status of their headache pain on a four-point Likert scale (i.e., 0=none, 1=mild, 2=moderate, 3=severe).
Time frame: 2 hours
The proportion of patients having the absence of the most bothersome migraine-associated symptom at 2 hours.
The most bothersome migraine-associated symptom is prospectively identified at baseline. It is measured by asking the patients to self-report the current status of their associated symptom as present or absent.
Time frame: 2 hours
The proportion of patients having the absence of nausea, photophobia, phonophobia, and neck/shoulder pain at 2 hours.
Measured by asking the patients to self-report the current status of their associated symptoms as present or absent.
Time frame: 24 and 48 hours
The proportion of patients who used rescue medications within 24 hours.
Time frame: 24 hours
The proportion of patients who are "sustained pain-free" at 24-hours and 48-hours.
Defined as having no headache pain at 2 hours after the dose, with no use of rescue medication and no relapse of headache pain within 24 hours (24-hour sustained pain-free) or 48 hours (48-hour sustained pain-free) after administration of the investigational drug.
Time frame: 48 hours.
The proportion of patients who had headache pain relapse within 48 hours
Defined as the return of headache of any severity within 48 hours after administration of the investigational drug, when the patient was pain-free at 2 hours after the administration of the investigational drug.
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Time frame: 48 hours
The proportion of patients who experienced adverse events
Time frame: 48 hours