Back to resultsSafety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
Primary Purpose
Migraine Headache
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
INP104
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache
Eligibility 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.
Sites / Locations
- Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest
- Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203
- Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road
- Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191
- Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415
- Excell Research, 3998 Vista Way
- Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200
- Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420
- Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100
- Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760
- ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200
- Clinical Research of Central Florida, 500 East Central Avenue
- Synexus - Atlanta, 6065 Roswell Road, Suite 820
- Cedar Crosse Research Center, 800 South Wells Street, Suite M-15
- Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive
- Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor
- Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513
- Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417
- Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103
- StudyMetrix Research, LLC., 3862 Mexico Road
- Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road
- Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130
- Hassman Research Institute, 175 Cross Keys Road, Suite 300B
- Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO
- CNS Research Science, Inc., 80-15 164th Street
- Aventiv Research, 99 North Brice Road, Suite 260
- OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5
- Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350
- Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4
- Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2
- MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109
- Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420
- FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300
- Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220
- Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B
- National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INP104
Arm Description
24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants
Outcomes
Primary Outcome Measures
Number of Participants With Serious Adverse Events (SAEs)
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)
Number of participants with non-serious treatment emergent adverse events (AEs), whether or not related to study drug.
Change in Nasal Mucosa
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03557333
Brief Title
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impel Pharmaceuticals
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INP104
Arm Type
Experimental
Arm Description
24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants
Intervention Type
Combination Product
Intervention Name(s)
INP104
Other Intervention Name(s)
Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device, INP104, POD-DHE
Intervention Description
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 Measure Information:
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug.
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)
Title
Number of Participants With Non-serious Treatment Emergent Adverse Events (AEs)
Description
Number of participants with non-serious treatment emergent adverse events (AEs), whether or not related to study drug.
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)
Title
Change in Nasal Mucosa
Description
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).
Time Frame
Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)
Title
Change in Olfactory Function
Description
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.
Time Frame
Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Excell Research, 3998 Vista Way
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Clinical Research of Central Florida, 500 East Central Avenue
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Synexus - Atlanta, 6065 Roswell Road, Suite 820
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Cedar Crosse Research Center, 800 South Wells Street, Suite M-15
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
StudyMetrix Research, LLC., 3862 Mexico Road
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Hassman Research Institute, 175 Cross Keys Road, Suite 300B
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
CNS Research Science, Inc., 80-15 164th Street
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Aventiv Research, 99 North Brice Road, Suite 260
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/Recalls/
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
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