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
Results First Posted : February 12, 2021
Last Update Posted : March 11, 2021
|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|
|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.
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From study enrollment up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group) ]Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug.
- Number of Participants With Non-serious Treatment Emergent Adverse Events (AEs) [ Time Frame: From first use of INP104 up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group) ]Number of participants with non-serious treatment emergent adverse events (AEs), whether or not related to study drug.
- Change in Nasal Mucosa [ Time Frame: Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group) ]Mean change from baseline in Quantitative Scoring Scale for Evaluation of the Nasal Mucosa (QSS-NM) score, reported at designated intervals on study. This scale was scored by otolaryngologists during routine endoscopy of the upper nasal cavity of participants. A minimum score of 0 means no issues were detected. A maximum score of 34 indicates severe issues (worse outcome).
- Change in Olfactory Function [ Time Frame: Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group) ]Mean change from baseline in olfactory function score, assessed using the University of Pennsylvania Smell Identification Test (UPSIT), and reported at designated intervals on study. The UPSIT is a 40 question scratch and sniff test of olfactory function. The minimum score of 0 indicates worst olfactory function, and the maximum score of 40 indicates the highest level of olfactory function detectable by the test.
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