Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine

Summary

This is a randomized, double-blind, multi-center, parallel-group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo.

Timeline

Start

2016-06

Primary completion

2017-01

Completion

2017-01

Outcome

Met primary endpoint

paper Of patients treated with ADAM zolmitriptan 3.8 mg or placebo, 41.5% and 14.2%, respectively were pain-free 2 hours post-dose ( p = 0.0001) PMID 29022755 ↗

paper 68.3% and 42.9% were free from their most bothersome other symptom ( p = 0.0009). PMID 29022755 ↗

Publications

• Tepper SJ, Dodick DW, Schmidt PC, Kellerman DJ. Efficacy of ADAM Zolmitriptan for the Acute Treatment of Difficult-to-Treat Migraine Headaches. Headache. 2019 Apr;59(4):509-517. doi: 10.1111/head.13482. Epub 2019 Jan 30.
• Spierings EL, Brandes JL, Kudrow DB, Weintraub J, Schmidt PC, Kellerman DJ, Tepper SJ. Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine. Cephalalgia. 2018 Feb;38(2):215-224. doi: 10.1177/0333102417737765. Epub 2017 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zolmitriptan	Small molecule	1 mg	Other
Subject	Zolmitriptan	Small molecule	1.9 mg	Other
Subject	Zolmitriptan	Small molecule	3.8 mg	Other

Indications