Recruiting

Phase 2

ASY202Study 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

Sponsor:

Aspeya, Inc.

Code:

NCT07646613

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ASY202

Placebo

Study Details

Brief 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. 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

Study ID

NCT07646613

Start date

May 19, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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.
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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ASY202, Then Placebo

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.

experimental: Placebo, Then ASY202

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.

Interventions

ASY202

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).

Placebo

Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

Primary outcome measure

Proportion of patients with freedom from headache pain at 2 hours post-dose [ Time Frame: 2 hours Post-Dose ]

Central Contacts and Locations

Central contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Locations

Arizona Research Center

Recruiting

Phoenix, Arizona, United States, 85053

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Synergy San Diego

Recruiting

Lemon Grove, California, United States, 91945

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Sunwise Clinical Research, Llc

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

New England Institute for Clinical Research

Recruiting

Stamford, Connecticut, United States, 06905

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Chase Medical Research

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Clinical Neuroscineces Solutions - Orlando

Recruiting

Orlando, Florida, United States, 32801

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Clinical Neuroscineces Solutions

Recruiting

Orlando, Florida, United States, 32806

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Conquest Research

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Boston Clinical Trials

Recruiting

Roslindale, Massachusetts, United States, 02131

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Mass. Institute of Clinical Research

Recruiting

Westborough, Massachusetts, United States, 01581

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

StudyMetrix Research

Recruiting

City of Saint Peters, Missouri, United States, 63303

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

M3 Wake Research - Las Vegas Rainbow

Recruiting

Las Vegas, Nevada, United States, 89118

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

CenExel Marlton NJ

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

SPRI Clinical Trials

Recruiting

Brooklyn, New York, United States, 11235

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

M3 Wake Research

Recruiting

Raleigh, North Carolina, United States, 27612

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

CNS Healthcare

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Clinical Research Associates, Inc.

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

FutureSearch Trials of Neurology

Recruiting

Austin, Texas, United States, 78731

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

FutureSearch Trials of Dallas

Recruiting

Dallas, Texas, United States, 75251

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

Highland Clinical Research

Recruiting

Salt Lake City, Utah, United States, 84124

Contacts

Eken

+41 76 358 88 30 clinicaltrials@aspeya.com

More Information

Sponsor

Aspeya, Inc.

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

Migraine
DHE
Dihydroergotamine Mesylate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Aspeya, Inc. on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.