Migraine Disorders Clinical Trial
Official title:
An Open-Label Study to Evaluate the Safety of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine Over 12 Months
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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