A Phase 3 interventional study of INP104 in Migraine Headache, sponsored by Impel Pharmaceuticals. Completed at 36 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by Impel Pharmaceuticals · Phase 3, Interventional, and Treatment
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Among 696 studies in Migraine Disorders with a site in United States — 93 open to participants now, 115 under way, 27 of them phase 3. Migraine Disorders · United States.
Among the 696 studies in Migraine Disorders with a site in United States, this one is the 138th largest by enrollment of the 609 interventional ones that give a count, is one of 27 that started in 2018, is one of 136 in phase 3, and was the 383rd registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →93 of the 696 studies in Migraine Disorders with a site in United States are open now. Recruiting first, the newest first:
Salvia BioElectronics · Sites in United States
Ages 22–84
University of Colorado, Denver · Sites in United States
Ages 12–17
Columbia University · Sites in United States
Ages 18–55
TriGemX Bio, Inc. · Sites in United States
Ages 18–75
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
696 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 66 · Phase 2 113 · Phase 3 151 · Phase 4 101
First in 1999; this study’s year is marked. 27 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 360 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 78 across the 609 interventional studies, 195 across the 84 observational. Of the 526 that completed or were terminated, 305 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
344 of 696 have an industry lead sponsor. The 10 most frequent:
Impel Pharmaceuticals is the lead sponsor of 5 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Impel Pharmaceuticals has 2 studies filed under Migraine Disorders — fewer than ten, so there is no comparison to draw.
47 of the studies in Migraine Disorders with a site in United States that are under way reach primary completion within a year, 11 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06641466Phase 3PfizerA Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine | 2026-11-29 |
| NCT07645924Phase 3TriGemX Bio, Inc.A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine | 2027-02 |
| NCT05598723Phase 3Naval Medical Center Camp LejeuneBOTOX® vs. XEOMIN® for Chronic Migraine | 2027-02-24 |
| NCT07018700Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine | 2027-03 |
| NCT07018713Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine | 2027-03 |
Add all 47 to your calendar (.ics) → With an account.
Among the 696 studies in Migraine Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants
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.
Also known as: Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device, INP104, POD-DHE
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug.
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 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.
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)
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).
Time frame: 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.
Time frame: Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)
| Milestone | 24-Week Treatment Group |
|---|---|
| Started | 354 |
| Completed | 262 |
| Not completed | 92 |
Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug.
| Participants | 24-Week Treatment Group | 52-Week Treatment Group |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 5 | 3 |
Number of participants with non-serious treatment emergent adverse events (AEs), whether or not related to study drug.
| Participants | 24-Week Treatment Group | 52-Week Treatment Group |
|---|---|---|
| Number of Participants With Non-serious Treatment Emergent Adverse Events (AEs) | 241 | 61 |
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).
| mean change in score on a scale | 24-Week Treatment Group | 52-Week Treatment Group |
|---|---|---|
| Week 4 | 0.2 ± 1.26 | 0.0 ± 0.62 |
| Week 8 | 0.2 ± 1.43 | 0.1 ± 0.91 |
| Week 12 | 0.1 ± 0.93 | 0.1 ± 0.78 |
| Week 24 | 0.1 ± 0.88 | 0.0 ± 0.79 |
| Week 36 | — | -0.1 ± 0.68 |
| Week 52 | — | -0.1 ± 0.61 |
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.
| mean change in score | 24-Week Treatment Group | 52-Week Treatment Group |
|---|---|---|
| Week 12 | -0.48 ± 2.690 | -0.18 ± 2.573 |
| Week 24 | -0.22 ± 2.270 | 0.03 ± 2.373 |
| Week 36 | — | -0.13 ± 2.930 |
| Week 52 | — | -0.80 ± 2.710 |
Collected over Week 0 to Week 24 (for the 24-Week Treatment Group) and Week 0 to Week 52 (for the 52-Week Treatment Group). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 24-Week Treatment Group | 0/354 (0%) | 5/354 (1.4%) | 241/354 (68.1%) |
| 52-Week Treatment Group | 0/73 (0%) | 3/73 (4.1%) | 61/73 (83.6%) |
| Event | 24-Week Treatment Group | 52-Week Treatment Group |
|---|---|---|
| Intestinal obstructionGastrointestinal disorders | 0/354 | 1/73 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/354 | 1/73 |
| Ovarian massReproductive system and breast disorders | 1/354 | 1/73 |
| Visual impairmentEye disorders | 1/354 | 0/73 |
| Clavicle fractureInjury, poisoning and procedural complications | 1/354 | 0/73 |
| Rib fractureInjury, poisoning and procedural complications | 1/354 | 0/73 |
| Status migrainosusNervous system disorders | 1/354 | 0/73 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/354 | 0/73 |
| Event | 24-Week Treatment Group | 52-Week Treatment Group |
|---|---|---|
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 59/354 | 18/73 |
| Upper respiratory tract infectionInfections and infestations | 38/354 | 15/73 |
| NasopharyngitisInfections and infestations | 30/354 | 10/73 |
| NauseaGastrointestinal disorders | 28/354 | 8/73 |
| Olfactory test abnormalInvestigations | 9/354 | 7/73 |
| Urinary tract infectionInfections and infestations | 9/354 | 5/73 |
| Nasal discomfortRespiratory, thoracic and mediastinal disorders | 19/354 | 5/73 |
| SinusitisInfections and infestations | 13/354 | 4/73 |
| Product package associated injuryInjury, poisoning and procedural complications | 6/354 | 4/73 |
| DizzinessNervous system disorders | 8/354 | 4/73 |
| Age, Categorical(Participants) | 24-Week Treatment Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 353 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | 24-Week Treatment Group |
|---|---|
| Female | 304 |
| Male | 50 |
| Ethnicity (NIH/OMB)(Participants) | 24-Week Treatment Group |
|---|---|
| Hispanic or Latino | 29 |
| Not Hispanic or Latino | 324 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | 24-Week Treatment Group |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 79 |
| White | 266 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | 24-Week Treatment Group |
|---|---|
| United States | 354 |
| Mean number of migraines in 28-day baseline period(number of migraines) | 24-Week Treatment Group |
|---|---|
| Mean | 4.60 ± 2.313 |
| Mean duration of migraine history(years) | 24-Week Treatment Group |
|---|---|
| Mean | 19.5 ± 12.13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2018 to primary completion in Mar 2020, 20 months.
Results were first posted in Feb 2021, 10 months after primary completion.
Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's 20 months is above that.
Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Impel Pharmaceuticals