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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ASY202, a migraine medicine breathed in through a handheld inhaler, in adults ages 18–65 with migraine. It checks how well the medicine treats migraine attacks, its safety, and its side effects. The study lasts about 16 weeks, and each person gets both ASY202 and a placebo (inactive treatment) at different times.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Can understand the study steps and give written consent to join.
- Are 18–65 years old at screening.
- Have a BMI of 18.5–35 at screening. BMI is a measure based on height and weight.
- Have a documented history of migraine for at least 1 year that meets standard diagnosis rules. Migraine may be with or without aura (warning signs such as changes in vision).
- Female participants must be unable to become pregnant or use the birth control required by the study.
Who can't join
- Have been diagnosed with a headache condition other than migraine.
- Have or have had blocked or narrowed heart arteries, heart artery spasms, serious heart rhythm problems, or poor blood flow in the body.
- Have had a procedure to open heart arteries, heart or blood vessel surgery, or sepsis (a dangerous reaction to infection).
- Have or have had blood vessel disease in the brain, including a stroke, mini-stroke, or bleeding in or around the brain.
- Have a mental health, memory, alcohol use, or drug use condition that the study doctor thinks could affect safety or taking part.
- Are allergic to or cannot safely take DHE, related ergot medicines, or any ingredient in the study medicine.
- Recently used medicines that affect CYP3A4, a protein that helps the body process drugs. The listed limits are 14 days for strong or moderate blockers and 28 days for boosters, or 5 drug half-lives (a measure of how long a drug stays in the body).
- Have other serious symptoms or current or past health conditions that the study doctor thinks could affect safety or study results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (20)
AZ
- Arizona Research Center · Phoenix, AZ 85053Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Phoenix
CA
- Synergy San Diego · Lemon Grove, CA 91945Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Lemon Grove
- Sunwise Clinical Research, Llc · Walnut Creek, CA 94596Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Walnut Creek
CT
- New England Institute for Clinical Research · Stamford, CT 06905Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Stamford
- Chase Medical Research · Waterbury, CT 06708Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Waterbury
FL
- Clinical Neuroscineces Solutions - Orlando · Orlando, FL 32801Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Orlando
- Clinical Neuroscineces Solutions · Orlando, FL 32806Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Orlando
GA
- Conquest Research · Atlanta, GA 30328Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Atlanta
MA
- Boston Clinical Trials · Roslindale, MA 02131Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Roslindale
- Mass. Institute of Clinical Research · Westborough, MA 01581Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Westborough
MO
- StudyMetrix Research · City of Saint Peters, MO 63303Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in City of Saint Peters
NC
- M3 Wake Research · Raleigh, NC 27612Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Raleigh
NJ
- CenExel Marlton NJ · Marlton, NJ 08053Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Marlton
NV
- M3 Wake Research - Las Vegas Rainbow · Las Vegas, NV 89118Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Las Vegas
NY
- SPRI Clinical Trials · Brooklyn, NY 11235Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Brooklyn
TN
- CNS Healthcare · Memphis, TN 38119Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Memphis
- Clinical Research Associates, Inc. · Nashville, TN 37203Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Nashville
TX
- FutureSearch Trials of Neurology · Austin, TX 78731Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Austin
- FutureSearch Trials of Dallas · Dallas, TX 75251Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Dallas
UT
- Highland Clinical Research · Salt Lake City, UT 84124Eken · Study contact · +41 76 358 88 30 · clinicaltrials@aspeya.comMore trials in Salt Lake City