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Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP-301)

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ClinicalTrials.gov Identifier: NCT03557333
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Impel NeuroPharma Inc.

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.

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)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : October 18, 2019
Estimated Study Completion Date : October 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: INP104
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.
Other Names:
  • Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device
  • INP104, POD-DHE




Primary Outcome Measures :
  1. Serious treatment emergent adverse events (SAEs) [ Time Frame: Up to 54 weeks ]
    Number of participants with SAEs

  2. Non-serious treatment emergent adverse events (AEs) [ Time Frame: Up to 54 weeks ]
    Number of participants with non-serious AEs

  3. 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.

  4. 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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Contacts
Contact: Maria Jeleva, PhD 1-206-489-2471 mjeleva@impelnp.com

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Sponsors and Collaborators
Impel NeuroPharma Inc.

Additional Information:
Responsible Party: Impel NeuroPharma Inc.
ClinicalTrials.gov Identifier: NCT03557333     History of Changes
Other Study ID Numbers: INP104-301
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Dihydroergotamine
Vasoconstrictor Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents