Conditions: Migraine Disorders
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 198
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: sumatriptan iontophoretic transdermal patch

Interventions: intervention 1: NP101
Intervention descriptions: intervention 1: NP101 study patch 4 hour application

Protocol document: