Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP-301)
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|ClinicalTrials.gov Identifier: NCT03557333|
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Combination Product: INP104||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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: Stop 301 Trial (Safety and Tolerability of POD-DHE)|
|Actual Study Start Date :||July 13, 2018|
|Actual Primary Completion Date :||March 17, 2020|
|Actual Study Completion Date :||March 17, 2020|
24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants
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.
- Serious treatment emergent adverse events (SAEs) [ Time Frame: Up to 54 weeks ]Number of participants with SAEs
- Non-serious treatment emergent adverse events (AEs) [ Time Frame: Up to 54 weeks ]Number of participants with non-serious AEs
- Change in nasal mucosa [ Time Frame: Baseline up to 52 weeks ]Measured by focused nasal examination by otolaryngologist following Nasal Examination Manual, scored from 0 (none) upwards to denote increasing degrees of change.
- Change in olfactory function [ Time Frame: Baseline up to 52 weeks ]Assessed using the University of Pennsylvania Smell Identification Test as described in the Nasal Examination Manual. Consists of 40-question exam giving overall test score for each participant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557333