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

Migraine Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557333
• Other study ID #: INP104-301
• Status: Completed
• Phase: Phase 3
• Start date: July 13, 2018
• Est. completion date: March 17, 2020

Study information

• Verified date: February 2021
• Source: Impel NeuroPharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

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.

Locations

Country	Name	City	State
United States	Synexus - Atlanta, 6065 Roswell Road, Suite 820	Atlanta	Georgia
United States	FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300	Austin	Texas
United States	Hassman Research Institute, 175 Cross Keys Road, Suite 300B	Berlin	New Jersey
United States	Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203	Birmingham	Alabama
United States	Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest	Birmingham	Alabama
United States	Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO	Brooklyn	New York
United States	Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road	Chandler	Arizona
United States	MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109	Chattanooga	Tennessee
United States	Cedar Crosse Research Center, 800 South Wells Street, Suite M-15	Chicago	Illinois
United States	Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200	Colorado Springs	Colorado
United States	Aventiv Research, 99 North Brice Road, Suite 260	Columbus	Ohio
United States	Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417	Edina	Minnesota
United States	OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5	Edmond	Oklahoma
United States	Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive	Evansville	Indiana
United States	Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130	Henderson	Nevada
United States	Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420	Jacksonville	Florida
United States	CNS Research Science, Inc., 80-15 164th Street	Jamaica	New York
United States	Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor	Lexington	Kentucky
United States	Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415	Long Beach	California
United States	Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513	Marrero	Louisiana
United States	Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420	Memphis	Tennessee
United States	Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B	Murray	Utah
United States	Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2	North Charleston	South Carolina
United States	Excell Research, 3998 Vista Way	Oceanside	California
United States	Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100	Orlando	Florida
United States	Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191	Phoenix	Arizona
United States	Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220	Plano	Texas
United States	Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350	Portland	Oregon
United States	National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140	Richmond	Virginia
United States	Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103	Saint Louis	Missouri
United States	StudyMetrix Research, LLC., 3862 Mexico Road	Saint Peters	Missouri
United States	Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4	Smithfield	Pennsylvania
United States	Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760	Tampa	Florida
United States	ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200	West Palm Beach	Florida
United States	Clinical Research of Central Florida, 500 East Central Avenue	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Impel NeuroPharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
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.	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).	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.	Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)

External Links

•   FDA Safety Alerts and Recalls