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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

2026년 9월 1일 업데이트: Aspeya, Inc.

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

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

108

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • California
      • Walnut Creek, California, 미국, 94596
        • 모병
        • Sunwise Clinical Research, LLC
        • 연락하다:
    • Florida
      • Orlando, Florida, 미국, 32801
        • 아직 모집하지 않음
        • Clinical Neuroscineces Solutions - Orlando
        • 연락하다:
      • Orlando, Florida, 미국, 32806
        • 아직 모집하지 않음
        • Clinical Neuroscineces Solutions
        • 연락하다:
    • Nevada
      • Las Vegas, Nevada, 미국, 89118
        • 아직 모집하지 않음
        • M3 Wake Research - Las Vegas Rainbow
        • 연락하다:
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 아직 모집하지 않음
        • Clinical Research Associates, Inc.
        • 연락하다:
    • Utah
      • Salt Lake City, Utah, 미국, 84124
        • 아직 모집하지 않음
        • Highland Research
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ASY202, Then Placebo
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.
조합 제품: 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).
조합 제품: Placebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
실험적: Placebo, Then ASY202
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.
조합 제품: 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).
조합 제품: Placebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of patients with freedom from headache pain at 2 hours post-dose
기간: 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.
2 hours Post-Dose

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of patients with freedom from the most bothersome symptom (MBS) at 2 hours post-dose.
기간: 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).
2 hours Post-Dose
Proportion of patients with relief from headache pain at 2 hours post-dose
기간: 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.
2 hours Post-Dose
Proportion of patients with sustained pain-free status from 2 to 24 hours post-dose
기간: 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)
2 to 24 hours post-dose
Proportion of patients with headache pain relief at 10 minutes post-dose
기간: 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.
10 minutes post-dose
Proportion of patients with headache pain relief at 30 minutes post-dose
기간: 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
30 minutes post-dose
Proportion of patients who do not use rescue medication within 24 hours post-dose
기간: 0 to 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.
0 to 24 hours post-dose
Proportion of patients returning to normal functional ability at predefined post-dose timepoints
기간: Up to 48 hours post-dose
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.
Up to 48 hours post-dose
Number of participants with treatment-emergent adverse events
기간: From Screening Visit, through study completion, an average of 16 weeks
A treatment-emergent adverse event (TEAE) is defined as any adverse event occurring or worsening after administration of study intervention.
From Screening Visit, through study completion, an average of 16 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Aspeya, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 19일

기본 완료 (추정된)

2027년 3월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2026년 5월 27일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 1일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • VFC202-201

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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