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Trial record 1 of 2 for:    INP104
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Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP-301)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557333
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Impel NeuroPharma Inc.

Tracking Information
First Submitted Date  ICMJE June 4, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date May 5, 2020
Actual Study Start Date  ICMJE July 13, 2018
Actual Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP-301)
Official Title  ICMJE 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)
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE 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.
Other Names:
  • Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device
  • INP104, POD-DHE
Study Arms  ICMJE Experimental: INP104
24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants
Intervention: Combination Product: INP104
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2020)
360
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2018)
200
Actual Study Completion Date  ICMJE March 17, 2020
Actual Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented diagnosis of migraine with or without aura, with at least 2 attacks per month for the previous 6 months.
  • Participants must be in good general health, with no significant medical history (excluding migraine).
  • Participants must have the ability and willingness to attend the necessary visits at the study center.
  • Participants must be able to provide the written informed consent prior to entry into the study.
  • Women of childbearing potential must agree to use adequate contraception (as defined in the protocol and by study personnel) during the study and for 30 days after the last dose fo the study drug.
  • Male participants and their partners must agree to use effective contraception (as defined in the protocol and by study personnel) during the study and for 30 days after the last dose of the study drug. Male participants should also refrain from sperm donation for 30 days after study completion.

Exclusion Criteria:

  • Subjects with trigeminal autonomic cephalalgias (including cluster headache, hemicrania syndromes and short-lasting unilateral, neuralgiform headache attacks with conjunctival injection and tearing), hemiplegic migraine, or migraine with brainstem aura (previously referred to as basilar migraines).
  • Subjects with chronic migraines, medication overuse headache or other chronic headache syndromes.
  • Subjects with ischemic heart disease or subjects with clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina.
  • Subjects with significant risk factors for coronary artery disease (CAD) including current use of nicotine-containing products, medical history of diabetes, uncontrolled hypertension (high blood pressure), known peripheral arterial disease, Raynaud's phenomenon, sepsis or vascular surgery (within 3 months prior to study start), or severely impaired hepatic or renal (kidney) function.
  • Subjects with recurrent sinusitis or epistaxis.
  • Subjects with a history or presence of alcoholism or drug abuse within 2 years prior to first study drug administration.
  • Women who are pregnant, or planning to get pregnant, or who are lactating while participating in the study.
  • Use of any medications prohibited by protocol.
  • Use of >12 days per month of triptan or ergot-based medication in the 2 months prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03557333
Other Study ID Numbers  ICMJE INP104-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Impel NeuroPharma Inc.
Study Sponsor  ICMJE Impel NeuroPharma Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Impel NeuroPharma Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP