At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
INP104combination
Likely dose
INP104 1.45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating INP104 for Migraine Headache. Completed, enrolled 360 participants across 36 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Headache
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartJul 2018
Primary CompletionMar 2020
TodayJul 2026
First PostedJun 15, 2018
Enrollment StartJul 13, 2018
Primary CompletionMar 17, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.0 years ago
Interventions
INP104combination
No more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril.