The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Naltrexone plus acetaminophen
Naltrexon (high dose) plus acetaminophen
Naltrexone Alone plus Placebo
Annette C. Toledano MD
North Miami, Florida, United States
% of patients reporting no headache pain.
Self-reported headache pain on a four-point Likert scale.
Time frame: 2 hours post-dose
% of patients having absence of most bothersome migraine-associated symptom (MBS).
MBS was prospectively identified at baseline. Self-reported MBS as present or absent.
Time frame: 2 hours post-dose
% of patients who have "sustained pain freedom"
Defined as having no headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain within 24 hours after administration of the investigational drug.
Time frame: 24-hour post-dose.
% of patients having absence of nausea, photophobia, phonophobia, and neck/shoulder pain
Self-reported the current status of their associated symptom as present or absent.
Time frame: 24-hour post-dose.
% of patients who used rescue medications
Time frame: 2-24 hours
% of patients who had headache pain relapse.
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.
Time frame: 2-48 hours
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Acetaminophen Alone plus Placebo
Two Placebo capsules