NCT00724815

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

The Efficacy and Tolerability of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: NuPathe Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects stayed in the study until they had treated one migraine headache with a study patch or two months after randomization, whichever occurred first. During a migraine headache, subjects rated their baseline headache pain severity in a Migraine Study Diary using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) and applied the study patch only if their score was 2 or 3 (i.e., qualifying migraine headache). In addition to headache pain severity, subjects also recorded the presence or absence of aura, nausea, phonophobia, and photophobia, as well as the location of their headache (unilateral or bilateral) and whether their headache increased with movement.

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
DRUG	NP101 - Sumatriptan iontophoretic transdermal patch	Sumatriptan iontophoretic transdermal patch
DRUG	Placebo	NP101 Placebo iontophoretic transdermal patch

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-07-30
• Last updated: 2016-02-04
• Results posted: 2013-05-07

Locations

34 sites across 1 country: United States