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
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
Placebo: Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
Study 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
Primary outcome measure(s)
- Proportion of patients with freedom from headache pain at 2 hours post-dose — 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.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | Recruiting |
| Synergy San Diego | Lemon Grove | California | Recruiting |
| Sunwise Clinical Research, Llc | Walnut Creek | California | Recruiting |
| New England Institute for Clinical Research | Stamford | Connecticut | Recruiting |
| Chase Medical Research | Waterbury | Connecticut | Recruiting |
| Clinical Neuroscineces Solutions - Orlando | Orlando | Florida | Recruiting |
| Clinical Neuroscineces Solutions | Orlando | Florida | Recruiting |
| Conquest Research | Atlanta | Georgia | Recruiting |
| Boston Clinical Trials | Roslindale | Massachusetts | Recruiting |
| Mass. Institute of Clinical Research | Westborough | Massachusetts | Recruiting |
| StudyMetrix Research | City of Saint Peters | Missouri | Recruiting |
| M3 Wake Research - Las Vegas Rainbow | Las Vegas | Nevada | Recruiting |
| CenExel Marlton NJ | Marlton | New Jersey | Recruiting |
| SPRI Clinical Trials | Brooklyn | New York | Recruiting |
| M3 Wake Research | Raleigh | North Carolina | Recruiting |
| CNS Healthcare | Memphis | Tennessee | Recruiting |
| Clinical Research Associates, Inc. | Nashville | Tennessee | Recruiting |
| FutureSearch Trials of Neurology | Austin | Texas | Recruiting |
| FutureSearch Trials of Dallas | Dallas | Texas | Recruiting |
| Highland Clinical Research | Salt Lake City | Utah | Recruiting |
More Aspeya, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07646613 on ClinicalTrials.gov ↗ ← All trials in the USA