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RecruitingPhase 2

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

Aspeya, Inc. · NCT07646613

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
108
US sites recruiting
20
Study start
May 19, 2026
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ASY202; Placebo

Conditions: Migraine

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Arizona Research Center

    Phoenix, AZ 85053

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Synergy San Diego

    Lemon Grove, CA 91945

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Sunwise Clinical Research, Llc

    Walnut Creek, CA 94596

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • New England Institute for Clinical Research

    Stamford, CT 06905

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Chase Medical Research

    Waterbury, CT 06708

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Clinical Neuroscineces Solutions - Orlando

    Orlando, FL 32801

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Clinical Neuroscineces Solutions

    Orlando, FL 32806

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Conquest Research

    Atlanta, GA 30328

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Boston Clinical Trials

    Roslindale, MA 02131

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Mass. Institute of Clinical Research

    Westborough, MA 01581

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • StudyMetrix Research

    City of Saint Peters, MO 63303

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • M3 Wake Research - Las Vegas Rainbow

    Las Vegas, NV 89118

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • CenExel Marlton NJ

    Marlton, NJ 08053

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • SPRI Clinical Trials

    Brooklyn, NY 11235

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • M3 Wake Research

    Raleigh, NC 27612

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • CNS Healthcare

    Memphis, TN 38119

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Clinical Research Associates, Inc.

    Nashville, TN 37203

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • FutureSearch Trials of Neurology

    Austin, TX 78731

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • FutureSearch Trials of Dallas

    Dallas, TX 75251

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

  • Highland Clinical Research

    Salt Lake City, UT 84124

    Site contact: Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com

Study contacts (from the official record)

  • Eken · +41 76 358 88 30 · clinicaltrials@aspeya.com
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Study Evaluating the Efficacy, Safety, and Tolerability of ASY202… (NCT07646613) | Bored Studies