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An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months — NP101-008  

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00792103
Study type Interventional
Source Teva Pharmaceutical Industries
Contact
Status Completed
Phase Phase 3
Start date January 2009
Completion date September 2010
View Details
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