Clinical Trials Logo
  1. Home
  2. Migraine Headache
  3. NCT03557333

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
View Details
See also
  Status Clinical Trial Phase
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Not yet recruiting NCT05943457 - Vitamin K2 Supplementation in Adult Episodic Migraine N/A
Completed NCT01211145 - Zomig - Treatment of Acute Migraine Headache in Adolescents Phase 4
Completed NCT00530517 - A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack Phase 2
Completed NCT00898677 - Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030) Phase 3
Recruiting NCT06459635 - Migraine Attack Pain Phase Prediction Study
Completed NCT03971071 - A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache Phase 4
Withdrawn NCT02706015 - Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks Phase 3
Completed NCT02518464 - Ticagrelor Therapy for RefrACTORy Migraine Study Phase 4
Terminated NCT02375789 - Intranasal Cooling for Symptomatic Relief of Migraine N/A
Terminated NCT00391755 - A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches Phase 4
Completed NCT03401346 - Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults Phase 1
Completed NCT05085483 - Ketone for Migraine Prevention N/A
Completed NCT01604785 - Low-dose Propofol for Pediatric Migraine Phase 2/Phase 3
Terminated NCT00804973 - Study in Participants With Acute Migraines Headaches Phase 2
Completed NCT03341689 - Psilocybin for the Treatment of Migraine Headache Phase 1
Completed NCT01630044 - Neurostimulation Device for Treatment of Migraine Headache N/A
Active, not recruiting NCT00285402 - Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine Phase 2
Completed NCT00203255 - Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache N/A
Recruiting NCT06046508 - Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)