Trials / Completed
CompletedNCT03557333
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (actual)
- Sponsor
- Impel Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | INP104 | No more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril. |
Timeline
- Start date
- 2018-07-13
- Primary completion
- 2020-03-17
- Completion
- 2020-03-17
- First posted
- 2018-06-15
- Last updated
- 2021-03-11
- Results posted
- 2021-02-12
Locations
36 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03557333. Inclusion in this directory is not an endorsement.