At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Efficacy and Tolerability of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled Study
In Brief
A Phase 3 clinical trial evaluating NP101 - Sumatriptan iontophoretic transdermal patch and Placebo for Migraine Disorders. Completed, enrolled 530 participants across 34 sites.
Detailed 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.
Study Details
Timeline
Interventions
Sumatriptan iontophoretic transdermal patch
NP101 Placebo iontophoretic transdermal patch