ASY202 for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 who have had migraines (with or without aura) for at least a year, are generally healthy, and can use contraception if needed. People with heart problems, certain blood vessel diseases, other headache types, serious health conditions, or allergies to DHE cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive either ASY202 or placebo via inhalation
Washout
A minimum of 7 days washout period between treatment periods
Treatment Period 2
Participants receive the alternate treatment (ASY202 or placebo) via inhalation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests an inhaled migraine medication called ASY202 against a placebo. Each participant will receive both treatments in different periods using a handheld dry powder inhaler during migraine attacks. The study is double-blind and lasts about 16 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
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Who Is Running the Clinical Trial?
Aspeya, Inc.
Lead Sponsor
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