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Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)

Migraine Headache Clinical Trial

Official title:
Open-label Study of Safety and Tolerability of Chronic Intermittent Usage for 24 or 52 Weeks of Intranasal Dihydroergotamine Mesylate (DHE) Administered Using the I123 Precision Olfactory Delivery (POD®) Device [INP104, POD-DHE] in Patients With Migraine Headache

Clinical Trial Summary

This study consists of a 4-week screening period, a 24-week treatment period for all participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a subset of at least 60 and up to 80 participants, and a 2-week post-treatment follow-up period.

Clinical Trial Description

This is an outpatient study in people who currently suffer a minimum of 2 migraines per month. During the study, participants will be instructed to use no more than 2 doses of the study drug INP104 within a 24-hour period, or 3 doses in a 7-day period. Participants will self-administer INP104 nasally and record their migraines in an eDiary. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03557333
Study type Interventional
Source Impel NeuroPharma Inc.
Contact
Status Completed
Phase Phase 3
Start date July 13, 2018
Completion date March 17, 2020
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