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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

2026年9月1日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

108

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Walnut Creek、California、アメリカ、94596
        • 募集
        • Sunwise Clinical Research, LLC
        • コンタクト：
    • Florida
      • Orlando、Florida、アメリカ、32801
        • まだ募集していません
        • Clinical Neuroscineces Solutions - Orlando
        • コンタクト：
      • Orlando、Florida、アメリカ、32806
        • まだ募集していません
        • Clinical Neuroscineces Solutions
        • コンタクト：
    • Nevada
      • Las Vegas、Nevada、アメリカ、89118
        • まだ募集していません
        • M3 Wake Research - Las Vegas Rainbow
        • コンタクト：
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • まだ募集していません
        • Clinical Research Associates, Inc.
        • コンタクト：
    • Utah
      • Salt Lake City、Utah、アメリカ、84124
        • まだ募集していません
        • Highland Research
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
組み合わせ製品：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).
組み合わせ製品：Placebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
実験的：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.
組み合わせ製品：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).
組み合わせ製品：Placebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Proportion of patients with freedom from headache pain at 2 hours post-dose
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of patients with freedom from the most bothersome symptom (MBS) at 2 hours post-dose.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Aspeya, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月19日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2027年3月1日

試験登録日

最初に提出

2026年5月27日

QC基準を満たした最初の提出物

2026年6月12日

最初の投稿 (実際)

2026年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月2日

QC基準を満たした最後の更新が送信されました

2026年9月1日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • VFC202-201

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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