Migraine HeadachePhase 3NCT03557333
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
A Phase 3 study testing INP104 in people with Migraine Headache, run by Impel Pharmaceuticals at 36 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- INP104
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 36 sitesUnited States
- Study dates
- 13 Jul 2018to 17 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Synexus - Atlanta, 6065 Roswell Road, Suite 820
Atlanta, Georgia, 30328
FutureSearch Trials of Neurology, 5508 Parkcrest Drive, Suite 300
Austin, Texas, 78731
Hassman Research Institute, 175 Cross Keys Road, Suite 300B
Berlin, New Jersey, 08009
Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest
Birmingham, Alabama, 35211
Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203
Birmingham, Alabama, 35235
Integrative Clinical Trials, 3288 Ocean Avenue, Unit # MO
Brooklyn, New York, 11229
Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road
Chandler, Arizona, 85224
MR - ClinSearch, LLC., 6035 Shallowford Road, Suite 109
Chattanooga, Tennessee, 37421
Cedar Crosse Research Center, 800 South Wells Street, Suite M-15
Chicago, Illinois, 60607
StudyMetrix Research, LLC., 3862 Mexico Road
City of Saint Peters, Missouri, 63303
Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200
Colorado Springs, Colorado, 80909
Aventiv Research, 99 North Brice Road, Suite 260
Columbus, Ohio, 43213
Synexus - Radiant Research, Inc., - Minneapolis, 7250 France Avenue South, Suite 417
Edina, Minnesota, 55435
OK Clinical Research, LLC., 120 North Bryant Avenue, Suite A5
Edmond, Oklahoma, 73034
Synexus - Clinical Research Advantage, Inc. - Allaw, 958C S. Kenmore Drive
Evansville, Indiana, 47714
Synexus - Clinical Research Advantage, Inc. - Rita B. Chuang, MD, LLC., 2629 West Horizon Ridge Parkway, Suite 130
Henderson, Nevada, 89052
Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420
Jacksonville, Florida, 32256
CNS Research Science, Inc., 80-15 164th Street
Jamaica, New York, 11432
Central Kentucky Research Associates, Inc., 3475 Richmond Road, 3rd Floor
Lexington, Kentucky, 40509
Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415
Long Beach, California, 90806
Tandem Clinical Research, LLC., 1111 Medical Center Boulevard, N513
Marrero, Louisiana, 70072
Clinical Neuroscience Solutions, Inc., 6401 Poplar Avenue, Suite 420
Memphis, Tennessee, 38119
Synexus - Radiant Research, Inc. - Salt Lake City, 5251 South Green Street, Suite 300B
Murray, Utah, 84123
Coastal Carolina Research Center, 9279 Medical Plaza Drive, Suite B2
North Charleston, South Carolina, 29406
Excell Research, 3998 Vista Way
Oceanside, California, 92056
Synexus - Clinical Research Advantage, Inc. - Omaha, 11020 Prairie Brook Road
Omaha, Nebraska, 68144
Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100
Orlando, Florida, 32801
Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191
Phoenix, Arizona, 85020
Synexus - Clinical Research Advantage, Inc. - Plano Internal Medicine Associates, PA., 6300 West Parker Road, Suite 220
Plano, Texas, 75093
Summit Research Network Oregon, 2701 North West Vaughn Street, Suite 350
Portland, Oregon, 97210
National Clinical Research, Inc., 2809 Emerywood Parkway, Suite 140
Richmond, Virginia, 23294
Frontier Clinical Research, LLC., 100 Ridge View Drive, Unit 4
Smithfield, Pennsylvania, 15478
Synexus - Radiant Research, Inc. - St. Louis, 675 Old Ballas Road, Suite 103
St Louis, Missouri, 63141
Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760
Tampa, Florida, 33634
ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200
West Palm Beach, Florida, 33407
Clinical Research of Central Florida, 500 East Central Avenue
Winter Haven, Florida, 33880
About this study
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
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.
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- INP104
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INP104Combination product
Also called Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device, INP104, POD-DHE
No more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril.
| Study group | Role | What they receive |
|---|---|---|
| INP104 | Experimental | 24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants Receives: Combination Product: INP104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start13 Jul 2018
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557333
- Sponsor's protocol ID
- INP104-301
- Status last verified
- Feb 2021
- First submitted
- 4 Jun 2018
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03557333
- Acronym / sponsor ID
- INP104-301
- Conditions
- Migraine Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Impel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 12 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INP104 | Experimental | Combination Product: INP10424-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INP104Also: Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device, INP104, POD-DHENo more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril. | Combination product | INP104 |
Primary outcome
Number of Participants With Serious Adverse Events (SAEs)
Time frame: 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.
Number of Participants With Non-serious Treatment Emergent Adverse Events (AEs)
Time frame: 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 Nasal Mucosa
Time frame: 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).
Change in Olfactory Function
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INP104 in people with Migraine Headache, run by Impel Pharmaceuticals at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (SAEs) (time frame: From study enrollment up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.