MigrainePhase 2NCT07646613
Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE] Inhalation Powder Delivered Via a Multidose Dry Powder Inhaler) for the Acute Treatment of Migraine in Adult Patients
A Phase 2 study testing ASY202 in people with Migraine, run by Aspeya, Inc. at 20 sites in United States.
Trial summary
This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- ASY202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 20 sitesUnited States
- Study dates
- 19 May 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Able to understand study procedures and provide written informed consent
- Male or female, 18-65 years of age at Screening
- BMI between 18.5-35 kg/m² at Screening
- Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- Female participants must be either:
- of non-childbearing potential, or
- of childbearing potential using protocol required contraception
Who cannot join
- Diagnosis of headache conditions other than migraine
- History or current diagnosis of coronary artery disease (CAD)
- History or current diagnosis of coronary artery vasospasm (including Printz-metal's angina), clinically significant arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation) or peripheral vascular disease, ischemic disease (e.g., Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia)
- History of percutaneous coronary intervention, cardiac surgery, sepsis or vascular surgery
- History or current diagnosis of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, or subarachnoid hemorrhage
- Known history or current diagnosis of psychological and/or psychiatric condition that, in the opinion of the Investigator, might interfere with study participation and assessments or participant safety. These conditions may include depression, psychosis, schizophrenia, bipolar disorder, dementia, alcoholism, drug abuse, etc.
Show all 9Show fewer
- Known allergic reactions, hypersensitivity, or contraindications to DHE, other ergot-derived products, or any other excipient in the formulation
- Use of strong or moderate CYP3A4 inhibitors within 14 days (or 5 half-lives) or CYP3A4 inducers within 28 days (or 5 half-lives) prior to Randomization
- Any clinically significant symptoms or conditions at screening, other than migraine, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions, or history of such conditions that in the opinion of the Investigator, might interfere with study assessments or participant safety
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Conquest Research
Atlanta, Georgia, 30328
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
FutureSearch Trials of Neurology
Austin, Texas, 78731
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
SPRI Clinical Trials
Brooklyn, New York, 11235
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, 75251
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
M3 Wake Research - Las Vegas Rainbow
Las Vegas, Nevada, 89118
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Synergy San Diego
Lemon Grove, California, 91945
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
CenExel Marlton NJ
Marlton, New Jersey, 08053
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
CNS Healthcare
Memphis, Tennessee, 38119
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Clinical Neuroscineces Solutions - Orlando
Orlando, Florida, 32801
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Clinical Neuroscineces Solutions
Orlando, Florida, 32806
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Arizona Research Center
Phoenix, Arizona, 85053
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
M3 Wake Research
Raleigh, North Carolina, 27612
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Boston Clinical Trials
Roslindale, Massachusetts, 02131
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Highland Clinical Research
Salt Lake City, Utah, 84124
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Sunwise Clinical Research, Llc
Walnut Creek, California, 94596
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Chase Medical Research
Waterbury, Connecticut, 06708
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
- Recruiting
Mass. Institute of Clinical Research
Westborough, Massachusetts, 01581
Eken, +41 76 358 88 30, clinicaltrials@aspeya.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover, Multi-center Clinical Trial for the Evaluation of Efficacy, Safety, and Tolerability of ASY202 for the Acute Treatment of Migraine in Adult Patients
This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur.
Following screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2.
The study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit.
- Conditions
- Migraine
- Being tested
- ASY202, Placebo
- Keywords
- Migraine, DHE, Dihydroergotamine Mesylate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASY202Combination product
ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).
PlaceboCombination product
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
| Study group | Role | What they receive |
|---|---|---|
| ASY202, Then Placebo | Experimental | ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device. Receives: Combination Product: ASY202; Combination Product: Placebo |
| Placebo, Then ASY202 | Experimental | In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2. Receives: Combination Product: ASY202; Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with freedom from headache pain at 2 hours post-dose
Proportion of patients achieving freedom from headache pain at 2 hours following administration of a single 2.0 mg dose of ASY202 compared with placebo. Headache pain freedom is defined as a reduction from moderate or severe headache intensity (score of 2 or 3 on a 4-point scale) at baseline (time 0) to no headache pain (score of 0 on the same 4-point scale) at 2 hours post-dose.
Measured: 2 hours Post-Dose
Secondary outcomes (8)
Proportion of patients with freedom from the most bothersome symptom (MBS) at 2 hours post-dose.
Proportion of patients achieving freedom from their most bothersome symptom (MBS), among photophobia, phonophobia, and nausea/vomiting, at 2 hours following administration of a single 2.0 mg dose of ASY202 compared with placebo. Freedom from the MBS is defined as the absence of the MBS at 2 hours post-dose if present at baseline (time 0).
Measured: 2 hours Post-Dose
Proportion of patients with relief from headache pain at 2 hours post-dose
Proportion of patients achieving headache pain relief at 2 hours following administration of a single 2.0 mg dose of ASY202 compared with placebo. Headache pain relief is defined as a reduction from moderate or severe headache intensity (score of 2 or 3 on a 4-point scale) at baseline (time 0) to mild or no headache pain (score of 1 or 0 on the same scale) at 2 hours post-dose.
Measured: 2 hours Post-Dose
Proportion of patients with sustained pain-free status from 2 to 24 hours post-dose
Proportion of patients free from headache pain at 2 hours post-dose and who remain headache pain-free through 24 hours post-dose without the use of rescue medication and without relapse of any headache pain (defined as maintaining a score of 0 on a 4-point scale from 2 to 24 hours)
Measured: 2 to 24 hours post-dose
Proportion of patients with headache pain relief at 10 minutes post-dose
Proportion of patients achieving headache pain relief at 10 minutes following administration of a single 2.0 mg dose of ASY202 compared with placebo. Relief is defined as a reduction from moderate or severe headache pain (score of 2 or 3 on a 4-point scale) at baseline to mild or no headache pain (score of 1 or 0 on the same scale) at 10 minutes post-dose.
Measured: 10 minutes post-dose
Proportion of patients with headache pain relief at 30 minutes post-dose
Proportion of patients achieving headache pain relief at 30 minutes following administration of a single 2.0 mg dose of ASY202 compared with placebo. Relief is defined as a reduction from moderate or severe headache pain (score of 2 or 3 on a 4-point scale) at baseline to mild or no headache pain (score of 1 or 0 on the same scale) at 30 minutes post-dose
Measured: 30 minutes post-dose
Proportion of patients who do not use rescue medication within 24 hours post-dose
Proportion of patients who do not require rescue medication within 24 hours following administration of a single 2.0 mg dose of ASY202 compared with placebo.
Measured: 0 to 24 hours post-dose
Proportion of patients returning to normal functional ability at predefined post-dose timepoints
Proportion of patients achieving normal functional ability, defined as a score of 0 on the 4-point Functional Impairment Scale, at prespecified timepoints up to 48 hours following administration of a single 2.0 mg dose of ASY202.
Measured: Up to 48 hours post-dose
Number of participants with treatment-emergent adverse events
A treatment-emergent adverse event (TEAE) is defined as any adverse event occurring or worsening after administration of study intervention.
Measured: From Screening Visit, through study completion, an average of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start19 May 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Eligible participants will be randomized to one of two treatment sequences in the crossover design: Sequence A: ASY202 administered during Treatment Period 1, followed by placebo during Treatment Period 2. Sequence B: Placebo administered during Treatment Period 1, followed by ASY202 during Treatment Period 2.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspeya, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646613
- Sponsor's protocol ID
- VFC202-201
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover, Multi-center Clinical Trial for the Evaluation of Efficacy, Safety, and Tolerability of ASY202 for the Acute Treatment of Migraine in Adult Patients
- ClinicalTrials.gov ID
- NCT07646613
- Acronym / sponsor ID
- VFC202-201
- Conditions
- Migraine
- Keywords
- Migraine, DHE, Dihydroergotamine Mesylate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Aspeya, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur.
Following screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2.
The study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized to one of two treatment sequences in the crossover design: Sequence A: ASY202 administered during Treatment Period 1, followed by placebo during Treatment Period 2. Sequence B: Placebo administered during Treatment Period 1, followed by ASY202 during Treatment Period 2.
| Arm | Type | Receives |
|---|---|---|
| ASY202, Then Placebo | Experimental | Combination Product: ASY202, Combination Product: PlaceboASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device. |
| Placebo, Then ASY202 | Experimental | Combination Product: ASY202, Combination Product: PlaceboIn Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to understand study procedures and provide written informed consent
- Male or female, 18-65 years of age at Screening
- BMI between 18.5-35 kg/m² at Screening
- Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- Female participants must be either:
Key exclusion criteria (9 listed)
- Diagnosis of headache conditions other than migraine
- History or current diagnosis of coronary artery disease (CAD)
- History or current diagnosis of coronary artery vasospasm (including Printz-metal's angina), clinically significant arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation) or peripheral vascular disease, ischemic disease (e.g., Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia)
- History of percutaneous coronary intervention, cardiac surgery, sepsis or vascular surgery
- History or current diagnosis of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, or subarachnoid hemorrhage
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 |
|---|---|---|
| ASY202ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI). | Combination product | ASY202, Then Placebo, Placebo, Then ASY202 |
| PlaceboPlacebo inhalation powder delivered via a dry powder inhaler (DPI) device. | Combination product | ASY202, Then Placebo, Placebo, Then ASY202 |
Primary outcome
Proportion of patients with freedom from headache pain at 2 hours post-dose
Time frame: 2 hours Post-Dose
Proportion of patients achieving freedom from headache pain at 2 hours following administration of a single 2.0 mg dose of ASY202 compared with placebo. Headache pain freedom is defined as a reduction from moderate or severe headache intensity (score of 2 or 3 on a 4-point scale) at baseline (time 0) to no headache pain (score of 0 on the same 4-point scale) at 2 hours post-dose.
8 secondary outcomes
Proportion of patients with freedom from the most bothersome symptom (MBS) at 2 hours post-dose.
Time frame: 2 hours Post-Dose
Proportion of patients with relief from headache pain at 2 hours post-dose
Time frame: 2 hours Post-Dose
Proportion of patients with sustained pain-free status from 2 to 24 hours post-dose
Time frame: 2 to 24 hours post-dose
Proportion of patients with headache pain relief at 10 minutes post-dose
Time frame: 10 minutes post-dose
Proportion of patients with headache pain relief at 30 minutes post-dose
Time frame: 30 minutes post-dose
Proportion of patients who do not use rescue medication within 24 hours post-dose
Time frame: 0 to 24 hours post-dose
Proportion of patients returning to normal functional ability at predefined post-dose timepoints
Time frame: Up to 48 hours post-dose
Number of participants with treatment-emergent adverse events
Time frame: From Screening Visit, through study completion, an average of 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASY202 in people with Migraine, run by Aspeya, Inc. at 20 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eken (+41 76 358 88 30, clinicaltrials@aspeya.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with freedom from headache pain at 2 hours post-dose (time frame: 2 hours Post-Dose). 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 9 Oct 2026.