Study VFC202-201 is a Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate 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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Combination product: ASY202; Combination product: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Eken; Phone Number: +41 76 358 88 30; Email: clinicaltrials@aspeya.com

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94596
      • Recruiting
      • Sunwise Clinical Research, Llc
      • Contact: Eken; Phone Number: +41 76 358 88 30; Email: clinicaltrials@aspeya.com
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Not yet recruiting
      • M3 Wake Research - Las Vegas Rainbow
      • Contact: Eken; Phone Number: +41 76 358 88 30; Email: clinicaltrials@aspeya.com
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Not yet recruiting
      • Highland Research
      • Contact: Eken; Phone Number: +41 76 358 88 30; Email: clinicaltrials@aspeya.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Combination product: 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).; Combination product: Placebo; Placebo inhalation powder delivered via a dry powder inhaler (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.	Combination product: 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).; Combination product: Placebo; Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours Post-Dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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)	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.	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	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.	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.	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.	From Screening Visit, through study completion, an average of 16 weeks

Collaborators and Investigators

• Sponsor: Aspeya, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; DHE; Dihydroergotamine Mesylate
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: VFC202-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No