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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, or 3 doses in a 7-day period. Participants will self-administer INP104 nasally and record their migraines in an eDiary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INP104 | Experimental | 24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INP104 | Combination Product | No more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug. | 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 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. | 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) |
| 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). | Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group) |
| 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. | Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest | Birmingham | Alabama | 35211 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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360 participants were enrolled and were dispensed INP104. Only those participants who dosed at least once with INP104 were included in the 24-Week Treatment Group, which was 354.
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| ID | Title | Description |
|---|---|---|
| FG000 | 24-Week Treatment Group | Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24-weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2019 | Jan 26, 2021 |
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| Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203 | Birmingham | Alabama | 35235 | United States |
| Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road | Chandler | Arizona | 85224 | United States |
| Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191 | Phoenix | Arizona | 85020 | United States |
| Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415 | Long Beach | California | 90806 | United States |
| Excell Research, 3998 Vista Way | Oceanside | California | 92056 | United States |
| Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200 | Colorado Springs | Colorado | 80909 | United States |
| Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420 | Jacksonville | Florida | 32256 | United States |
| Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100 | Orlando | Florida | 32801 | United States |
| Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760 | Tampa | Florida | 33634 | United States |
| ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200 | West Palm Beach | Florida | 33407 | United States |
| Clinical Research of Central Florida, 500 East Central Avenue | Winter Haven | Florida | 33880 | United States |
| Synexus - Atlanta, 6065 Roswell Road, Suite 820 | Atlanta | Georgia | 30328 | United States |
| Cedar Crosse Research Center, 800 South Wells Street, Suite M-15 | Chicago | Illinois | 60607 | United States |
| Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive | Evansville | Indiana | 47714 | United States |
| Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor | Lexington | Kentucky | 40509 | United States |
| Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513 | Marrero | Louisiana | 70072 | United States |
| Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417 | Edina | Minnesota | 55435 | United States |
| StudyMetrix Research, LLC., 3862 Mexico Road | City of Saint Peters | Missouri | 63303 | United States |
| Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103 | St Louis | Missouri | 63141 | United States |
| Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road | Omaha | Nebraska | 68144 | United States |
| Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130 | Henderson | Nevada | 89052 | United States |
| Hassman Research Institute, 175 Cross Keys Road, Suite 300B | Berlin | New Jersey | 08009 | United States |
| Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO | Brooklyn | New York | 11229 | United States |
| CNS Research Science, Inc., 80-15 164th Street | Jamaica | New York | 11432 | United States |
| Aventiv Research, 99 North Brice Road, Suite 260 | Columbus | Ohio | 43213 | United States |
| OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5 | Edmond | Oklahoma | 73034 | United States |
| Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350 | Portland | Oregon | 97210 | United States |
| Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4 | Smithfield | Pennsylvania | 15478 | United States |
| Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2 | North Charleston | South Carolina | 29406 | United States |
| MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109 | Chattanooga | Tennessee | 37421 | United States |
| Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420 | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300 | Austin | Texas | 78731 | United States |
| Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220 | Plano | Texas | 75093 | United States |
| Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B | Murray | Utah | 84123 | United States |
| National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140 | Richmond | Virginia | 23294 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 24-Week Treatment Group | Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24-weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||||
| Mean number of migraines in 28-day baseline period | Mean | Standard Deviation | number of migraines |
| |||||||||||||||||||
| Mean duration of migraine history | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug. | Posted | Count of Participants | Participants | From study enrollment up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group) |
|
|
| ||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Count of Participants | Participants | 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) |
|
| |||||||||||||||||||||||||||||||
| Primary | 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). | Only those participants with assessments at baseline and at the indicated time point have data analyzed in that row. | Posted | Mean | Standard Deviation | mean change in score on a scale | Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group) |
|
| |||||||||||||||||||||||||||||
| Primary | 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. | Only those subjects with data at baseline and the indicated time point are included in the analysis for that row. | Posted | Mean | Standard Deviation | mean change in score | Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group) |
|
|
Week 0 to Week 24 (for the 24-Week Treatment Group) and Week 0 to Week 52 (for the 52-Week Treatment Group)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 24-Week Treatment Group | Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24 weeks. | 0 | 354 | 5 | 354 | 241 | 354 |
| EG001 | 52-Week Treatment Group | Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 52 weeks. Participants in this treatment group are subset of those included in the 24-Week Treatment Group. | 0 | 73 | 3 | 73 | 61 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual impairment | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Status migrainosus | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (21.0) | Systematic Assessment |
| |
| Ovarian mass | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Product package associated injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Olfactory test abnormal | Investigations | MedDRA (21.0) | Systematic Assessment | Olfactory test abnormal events were asymptomatic decreases of 5 or more points from baseline on UPSIT score. |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Product taste abnormal | Product Issues | MedDRA (21.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Menopause | Social circumstances | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Craig, PhD (Medical Writer) | Impel NeuroPharma | 206-568-1466 | kcraig@impelnp.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2020 | Jan 26, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004087 | Dihydroergotamine |
| ID | Term |
|---|---|
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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