Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP-301)
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|ClinicalTrials.gov Identifier: NCT03557333|
Recruitment Status : Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : June 29, 2018
Impel NeuroPharma Inc.
Information provided by (Responsible Party):
Impel NeuroPharma Inc.
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. 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, 3 doses in a 7-day period. Participants will self-administer INP104 intranasally.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Combination Product: INP104||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 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)|
|Estimated Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||July 2, 2019|
|Estimated Study Completion Date :||July 2, 2019|
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.
Primary Outcome Measures :
- 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.
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