Clinical trial NCT03557333: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Headache
Lead sponsor: Impel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From study enrollment up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group)
measure: Number of Participants With Non-serious Treatment Emergent Adverse Events (AEs)
timeFrame: 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)
measure: Change in Nasal Mucosa
timeFrame: Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)
measure: Change in Olfactory Function
timeFrame: Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203
state: Alabama
city: Chandler
country: United States
facility: Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road
state: Arizona
city: Phoenix
country: United States
facility: Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191
state: Arizona
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415
state: California
city: Oceanside
country: United States
facility: Excell Research, 3998 Vista Way
state: California
city: Colorado Springs
country: United States
facility: Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200
state: Colorado
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100
state: Florida
city: Tampa
country: United States
facility: Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760
state: Florida
city: West Palm Beach
country: United States
facility: ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida, 500 East Central Avenue
state: Florida
city: Atlanta
country: United States
facility: Synexus - Atlanta, 6065 Roswell Road, Suite 820
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center, 800 South Wells Street, Suite M-15
state: Illinois
city: Evansville
country: United States
facility: Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive
state: Indiana
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513
state: Louisiana
city: Edina
country: United States
facility: Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417
state: Minnesota
city: Saint Louis
country: United States
facility: Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research, LLC., 3862 Mexico Road
state: Missouri
city: Omaha
country: United States
facility: Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road
state: Nebraska
city: Henderson
country: United States
facility: Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute, 175 Cross Keys Road, Suite 300B
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO
state: New York
city: Jamaica
country: United States
facility: CNS Research Science, Inc., 80-15 164th Street
state: New York
city: Columbus
country: United States
facility: Aventiv Research, 99 North Brice Road, Suite 260
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350
state: Oregon
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2
state: South Carolina
city: Chattanooga
country: United States
facility: MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300
state: Texas
city: Plano
country: United States
facility: Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220
state: Texas
city: Murray
country: United States
facility: Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B
state: Utah
city: Richmond
country: United States
facility: National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140
state: Virginia
Study officials:
References: