RecruitingPhase 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 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


Sponsor

Aspeya, Inc.

Enrollment

108 participants

Start Date

May 19, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ASY202 and Placebo for people with migraine. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTASY202

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_PRODUCTPlacebo

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


Locations(6)

Sunwise Clinical Research, Llc

Walnut Creek, California, United States

Clinical Neuroscineces Solutions - Orlando

Orlando, Florida, United States

Clinical Neuroscineces Solutions

Orlando, Florida, United States

M3 Wake Research - Las Vegas Rainbow

Las Vegas, Nevada, United States

Clinical Research Associates, Inc.

Nashville, Tennessee, United States

Highland Research

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT07646613


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