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

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).

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From Screening Visit, through study completion, an average of 16 weeks