The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine

Summary

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.

Timeline

Start

2009-01

Primary completion

2009-07

Completion

2009-07

Outcome

Met primary endpoint

paper Significantly more patients treated with the sumatriptan iontophoretic transdermal system compared with placebo experienced freedom from headache pain PMID 22694484 ↗

Publications

• Goldstein J, Smith TR, Pugach N, Griesser J, Sebree T, Pierce M. A sumatriptan iontophoretic transdermal system for the acute treatment of migraine. Headache. 2012 Oct;52(9):1402-10. doi: 10.1111/j.1526-4610.2012.02198.x. Epub 2012 Jun 13.

Drugs

Indications