Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
- Conditions
- Migraine Headache
- Interventions
- Combination Product: INP104
- Registration Number
- NCT03557333
- Lead Sponsor
- Impel Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description INP104 INP104 24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants
- Primary Outcome Measures
Name Time Method Change in Nasal Mucosa Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group) 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).
Number of Participants With Non-serious Treatment Emergent Adverse Events (AEs) 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) Number of participants with non-serious treatment emergent adverse events (AEs), whether or not related to study drug.
Change in Olfactory Function Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group) 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.
Number of Participants With Serious Adverse Events (SAEs) 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 Serious Adverse Events (SAEs) whether or not related to study drug.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Cedar Crosse Research Center, 800 South Wells Street, Suite M-15
🇺🇸Chicago, Illinois, United States
ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200
🇺🇸West Palm Beach, Florida, United States
Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130
🇺🇸Henderson, Nevada, United States
Hassman Research Institute, 175 Cross Keys Road, Suite 300B
🇺🇸Berlin, New Jersey, United States
Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road
🇺🇸Chandler, Arizona, United States
Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100
🇺🇸Orlando, Florida, United States
Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200
🇺🇸Colorado Springs, Colorado, United States
Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417
🇺🇸Edina, Minnesota, 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. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest
🇺🇸Birmingham, Alabama, United States
Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760
🇺🇸Tampa, Florida, United States
Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road
🇺🇸Omaha, Nebraska, United States
Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203
🇺🇸Birmingham, Alabama, United States
Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415
🇺🇸Long Beach, California, United States
Excell Research, 3998 Vista Way
🇺🇸Oceanside, California, United States
Synexus - Atlanta, 6065 Roswell Road, Suite 820
🇺🇸Atlanta, Georgia, United States
Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive
🇺🇸Evansville, Indiana, United States
Clinical Research of Central Florida, 500 East Central Avenue
🇺🇸Winter Haven, Florida, United States
Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor
🇺🇸Lexington, Kentucky, United States
Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513
🇺🇸Marrero, Louisiana, 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
Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO
🇺🇸Brooklyn, New York, United States
CNS Research Science, Inc., 80-15 164th Street
🇺🇸Jamaica, New York, United States
Aventiv Research, 99 North Brice Road, Suite 260
🇺🇸Columbus, Ohio, United States
OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5
🇺🇸Edmond, Oklahoma, United States
Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350
🇺🇸Portland, Oregon, United States
Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4
🇺🇸Smithfield, Pennsylvania, United States
MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109
🇺🇸Chattanooga, Tennessee, United States
Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2
🇺🇸North Charleston, South Carolina, United States
Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420
🇺🇸Memphis, Tennessee, United States
FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300
🇺🇸Austin, Texas, United States
Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B
🇺🇸Murray, Utah, United States
Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220
🇺🇸Plano, Texas, United States
National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140
🇺🇸Richmond, Virginia, United States