This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours after patch activation. Key secondary objectives included: 1. The proportion of subjects who were nausea free at two hours after patch activation. 2. The proportion of subjects who were photophobia free at two hours after patch activation. 3. The proportion of subjects who were phonophobia free at two hours after patch activation.
Subjects stayed in the study until they had treated one migraine headache with a study patch or two months after randomization, whichever occurred first. During a migraine headache, subjects rated their baseline headache pain severity in a Migraine Study Diary using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) and applied the study patch only if their score was 2 or 3 (i.e., qualifying migraine headache). In addition to headache pain severity, subjects also recorded the presence or absence of aura, nausea, phonophobia, and photophobia, as well as the location of their headache (unilateral or bilateral) and whether their headache increased with movement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
530
Sumatriptan iontophoretic transdermal patch
NP101 Placebo iontophoretic transdermal patch
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Newport Beach, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Santa Monica, California, United States
Unnamed facility
Fairfield, Connecticut, United States
Unnamed facility
Ocala, Florida, United States
Unnamed facility
Palm Beach Gardens, Florida, United States
Unnamed facility
Sunrise, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
...and 24 more locations
Pain Free at Two Hours
Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.
Time frame: 2 hours post patch activation
Photophobia Free at Two Hours
Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.
Time frame: 2 hours post patch activation
Phonophobia Free at Two Hours
Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.
Time frame: 2 hours post patch activation
Nausea Free at Two Hours
Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.
Time frame: 2 hours post patch activation
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