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

NCT03557333 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: INP104-301
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 36

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.

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

INP104

EXPERIMENTAL

24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants

Combination Product: INP104

Interventions

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.

Also known as: Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device, INP104, POD-DHE

INP104

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Impel Pharmaceuticals: lead

Study Sites (36)

Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest

Birmingham, Alabama, 35211, United States

Location

Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203

Birmingham, Alabama, 35235, United States

Location

Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road

Chandler, Arizona, 85224, United States

Location

Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191

Phoenix, Arizona, 85020, United States

Location

Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415

Long Beach, California, 90806, United States

Location

Excell Research, 3998 Vista Way

Oceanside, California, 92056, United States

Location

Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200

Colorado Springs, Colorado, 80909, United States

Location

Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100

Orlando, Florida, 32801, United States

Location

Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760

Tampa, Florida, 33634, United States

Location

ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200

West Palm Beach, Florida, 33407, United States

Location

Clinical Research of Central Florida, 500 East Central Avenue

Winter Haven, Florida, 33880, United States

Location

Synexus - Atlanta, 6065 Roswell Road, Suite 820

Atlanta, Georgia, 30328, United States

Location

Cedar Crosse Research Center, 800 South Wells Street, Suite M-15

Chicago, Illinois, 60607, United States

Location

Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive

Evansville, Indiana, 47714, United States

Location

Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor

Lexington, Kentucky, 40509, United States

Location

Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513

Marrero, Louisiana, 70072, United States

Location

Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417

Edina, Minnesota, 55435, United States

Location

StudyMetrix Research, LLC., 3862 Mexico Road

City of Saint Peters, Missouri, 63303, United States

Location

Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103

St Louis, Missouri, 63141, United States

Location

Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road

Omaha, Nebraska, 68144, United States

Location

Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130

Henderson, Nevada, 89052, United States

Location

Hassman Research Institute, 175 Cross Keys Road, Suite 300B

Berlin, New Jersey, 08009, United States

Location

Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO

Brooklyn, New York, 11229, United States

Location

CNS Research Science, Inc., 80-15 164th Street

Jamaica, New York, 11432, United States

Location

Aventiv Research, 99 North Brice Road, Suite 260

Columbus, Ohio, 43213, United States

Location

OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5

Edmond, Oklahoma, 73034, United States

Location

Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350

Portland, Oregon, 97210, United States

Location

Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4

Smithfield, Pennsylvania, 15478, United States

Location

Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2

North Charleston, South Carolina, 29406, United States

Location

MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109

Chattanooga, Tennessee, 37421, United States

Location

Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300

Austin, Texas, 78731, United States

Location

Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220

Plano, Texas, 75093, United States

Location

Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B

Murray, Utah, 84123, United States

Location

National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140

Richmond, Virginia, 23294, United States

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Migraine Disorders

Interventions

Dihydroergotamine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Karen Craig, PhD (Medical Writer)
• Organization: Impel NeuroPharma

kcraig@impelnp.com

206-568-1466

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: July 13, 2018
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: March 11, 2021
• Results First Posted: February 12, 2021

Record last verified: 2021-02

Locations

US (36)