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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
Results First Posted : February 12, 2021
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Impel Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine Headache Combination Product: INP104 Phase 3

Detailed Description:
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, or 3 doses in a 7-day period. Participants will self-administer INP104 nasally and record their migraines in an eDiary.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: N/A
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
Actual Study Start Date : July 13, 2018
Actual Primary Completion Date : March 17, 2020
Actual Study Completion Date : March 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Impel Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Impel Pharmaceuticals:
Study Protocol  [PDF] April 26, 2019
Statistical Analysis Plan  [PDF] April 1, 2020

More Information
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Additional Information:

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Responsible Party: Impel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03557333    
Other Study ID Numbers: INP104-301
First Posted: June 15, 2018    Key Record Dates
Results First Posted: February 12, 2021
Last Update Posted: March 11, 2021
Last Verified: February 2021

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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:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
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