Conditions: Migraine Disorders
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 530
Healthy volunteers: no

Brief 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.

Arms:
arm 1: NP101 - sumatriptan iontophoretic transdermal patch arm 2: Placebo iontophoretic transdermal patch

Interventions: intervention 1: NP101 - Sumatriptan iontophoretic transdermal patch intervention 2: Placebo
Intervention descriptions: intervention 1: Sumatriptan iontophoretic transdermal patch intervention 2: NP101 Placebo iontophoretic transdermal patch

Protocol document: