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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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Dec 2026 → Mar 2027
See other at-risk trials from Aspeya, Inc.

Record History

  1. Trial sites expanded: 6 → 20 locations Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 4 of 8 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 4 of 8 entries
  2. Primary and study completion pushed from Dec 2026 to Mar 2027v4
  3. Trial sites expanded: 3 → 6 locationsv3
  4. Study title shortened, about 7 wordsv2 See this version in full on ClinicalTrials.gov ↗
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aspeya, Inc.
2 trials monitored
See 2 trials at risk
Migraine
467 trials monitored
See 24 trials at risk
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.
Trial Details
NCT Number NCT07646613
Lead Sponsor Aspeya, Inc.
Conditions Migraine
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov