Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine.

ABSTRACT:

Objective

To determine the long-term safety and tolerability profile of M207 in the acute treatment of migraine.

Background

M207 is an investigational microneedle-based system for intracutaneous delivery of zolmitriptan for the treatment of migraine attacks. Following on the positive results of a Phase 2/3 placebo-controlled efficacy study (ZOTRIP), this study was designed to evaluate the safety of this novel product during repeated use for the treatment of migraine attacks.

Methods

In this 6-12 month open-label, multicenter observational study, participants used an eDiary to record headache symptoms and adverse events at specified intervals up to 48 h following treatment of a qualifying attack with M207 3.8 mg (intracutaneous zolmitriptan). Participants underwent cli

SUBMITTER: Nahas SJ 

PROVIDER: S-EPMC8127195 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature