The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by: * Subject self-examination skin irritation scores * Adverse events * Changes in vital signs and ECG parameters The secondary objective is to evaluate the long term efficacy of NP101 as assessed by: * Headache pain free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Headache pain relief at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Nausea free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Phonophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Photophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Migraine free at two hours after patch activation for all initial acute migraine attacks treated with NP101 This study will use an open-label design to assess the long term safety of NP101 (sumatriptan iontophoretic transdermal patch). Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not contraindicated) and received treatment (patch activation) with the study patch for a qualifying migraine under study NP101-007 will be considered eligible for enrollment into the open-label study. Subjects will be expected to remain in the study for up to 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
198
NP101 study patch 4 hour application
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
Subject Self-examination of Skin Irritation
For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).
Time frame: 24 hours post patch activation
Pain Relief
Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.
Time frame: 2 hours
Nausea Free
Nausea free at two hours after patch activation.
Time frame: 2 hours
Phonophobia Free
Phonophobia free at two hours after patch activation.
Time frame: 2 hours
Photophobia Free
Photophobia free at two hours after patch activation.
Time frame: 2 hours
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