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

NCT07646613 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: VFC202-201
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

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

Keywords

Migraine; DHE; Dihydroergotamine Mesylate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Proportion of patients with freedom from the most bothersome symptom (MBS) at 2 hours post-dose.

  2 hours Post-Dose

• Proportion of patients with relief from headache pain at 2 hours post-dose

  2 hours Post-Dose

• Proportion of patients with sustained pain-free status from 2 to 24 hours post-dose

  2 to 24 hours post-dose

• Proportion of patients with headache pain relief at 10 minutes post-dose

  10 minutes post-dose

• Proportion of patients with headache pain relief at 30 minutes post-dose

  30 minutes post-dose

Study Arms (2)

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.

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.

Combination Product: ASY202; Combination Product: Placebo

Interventions

ASY202 COMBINATION_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).

ASY202, Then Placebo; Placebo, Then ASY202

Placebo COMBINATION_PRODUCT

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

ASY202, Then Placebo; Placebo, Then ASY202

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aspeya, Inc.: lead

Study Sites (3)

Sunwise Clinical Research, Llc

Walnut Creek, California, 94596, United States

RECRUITING

M3 Wake Research - Las Vegas Rainbow

Las Vegas, Nevada, 89118, United States

NOT YET RECRUITING

Highland Research

Salt Lake City, Utah, 84124, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Eken

CONTACT

+41 76 358 88 30; clinicaltrials@aspeya.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sponsor, contract research organization (CRO), participants, investigators, and study personnel involved in clinical assessments will remain blinded to treatment assignment throughout the study. ASY202 and placebo will be identical in appearance, packaging, labelling, and administration to ensure blinding is maintained.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 15, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

US (3)