A Phase 1 interventional study of INP104 and Dihydroergotamine Mesylate (DHE) in Migraine Headache, sponsored by Impel Pharmaceuticals. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by Impel Pharmaceuticals · Phase 1, Interventional, and Treatment
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Among 26 studies in Migraine Disorders with a site in Australia — 2 open to participants now, 4 under way, none of them phase 3. Migraine Disorders · Australia.
Among the 26 studies in Migraine Disorders with a site in Australia, this one is the 24th largest by enrollment, is one of 2 that started in 2017, is one of 4 in phase 1, and was the 10th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →2 of the 26 studies in Migraine Disorders with a site in Australia are open now. Recruiting first, the newest first:
Evommune, Inc. · Sites in Australia, United States, Canada and 1 more country
Ages 18–64
Salvia BioElectronics · Sites in Australia, Belgium, Netherlands
Ages 18–84
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
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 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 248 across the 26 interventional studies. Of the 22 that completed or were terminated, 11 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 26 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.
4 of the studies in Migraine Disorders with a site in Australia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06167655ShiraTronicsA PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM | 2027-03 |
| NCT06450444Salvia BioElectronicsThe RECLAIM Study. | 2027-04-01 |
| NCT07616128Evommune, Inc.Study of EVO756 in Adults With Migraine | 2027-10 |
| NCT06625060IpsenA Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults | 2027-10-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 26 studies in Migraine Disorders with a site in Australia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
A Phase I clinical trial to compare the bioavailability of dihydroergotamine mesylate (DHE) following a single dose administration of INP104 (DHE administered by I123 Precision Olfactory Delivery (POD) Device Nasal Spray) to that of D.H.E. 45 for Injection (Intravenous) and Migranal Nasal Spray in healthy adult subjects.
It is hypothesized that INP104 will address the current variability in nasal administration and give more reproducible dose delivery compared to Migranal nasal spray.
Blood concentrations of all three investigational products will be compared for 48 hours following dosing. The safety and tolerability of INP104 will be monitored throughout the study.
INP104 has been developed for the treatment of acute migraine headache. The device in which the drug will be delivered has been designed to deliver the medication to the upper nasal cavity with minimal variation in dose absorption, eg loss via dripping out of the nose or the dose being swallowed.
Approximately 36 participants in general good health (equal ratio of males and females desired) will be enrolled and will be allocated to receive 3 treatments in a randomized sequence. They will receive a single dose of INP104, a single dose of DHE via intravenous injection, and a single dose of Migranal Nasal Spray. There will be a wash out period where no treatment will be administered for 7 days in between each treatment. Participants are required to attend 3 inpatient periods and 1 final outpatient visit. Each participant will be in the study for up to 43 days.
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:
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose 1.45 mg Dihydroergotamine Mesylate (DHE), administered by I123 Precision Olfactory Delivery (POD) device nasal spray (INP104)
Combination Product: INP104
Single dose 1 mg Dihydroergotamine Mesylate (DHE) for intravenous injection
Drug: Dihydroergotamine Mesylate (DHE)
Single dose 2 mg Migranal Nasal Spray Dihydroergotamine Mesylate (DHE)
Combination Product: Migranal Nasal Spray
Dihydroergotamine Mesylate (DHE) administered via I123 Precision Olfactory Delivery (POD) Device
Dihydroergotamine Mesylate (DHE) injection (intravenous)
Dihydroergotamine Mesylate (DHE) delivered via Migranal Nasal Spray pump
DHE pharmacokinetics
Cmax
Time frame: 48 hours
DHE pharmacokinetics
Tmax
Time frame: 48 hours
DHE pharmacokinetics
AUC(0-t)
Time frame: 48 hours
DHE pharmacokinetics
kel
Time frame: 48 hours
DHE pharmacokinetics
T(1/2)
Time frame: 48 hours
DHE pharmacokinetics
AUC(0-inf)
Time frame: 48 hours
DHE pharmacokinetics
CL/F (CL for IV administration)
Time frame: 48 hours
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events after one dose of INP-104, Migranal Nasal Spray or DHE45 by IV injection
Time frame: Day 1 to day 22 post first dosing
8'-OH-DHE pharmacokinetics
Cmax
Time frame: 48 hours
8'-OH-DHE pharmacokinetics
Tmax
Time frame: 48 hours
8'-OH-DHE pharmacokinetics
AUC(0-t)
Time frame: 48 hours
8'-OH-DHE pharmacokinetics
kel
Time frame: 48 hours
8'-OH-DHE pharmacokinetics
T(1/2)
Time frame: 48 hours
8'-OH-DHE pharmacokinetics
AUC(0-inf)
Time frame: 48 hours
8'-OH-DHE pharmacokinetics
CL/F (CL for IV administration)
Time frame: 48 hours
Plan to share: No
Ran from Oct 2017 to primary completion in Dec 2017, 1 month.
Of 39 industry-sponsored phase 1 interventional studies under Migraine Disorders, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's 1 month is below that.
Counting every sponsor, half of 53 studies reached it within 6 months; a quarter within 2 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Impel Pharmaceuticals