Study VFC202-201 is a Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate 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
12 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
108
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Eken
- Numero di telefono: +41 76 358 88 30
- Email: clinicaltrials@aspeya.com
Luoghi di studio
-
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California
-
Walnut Creek, California, Stati Uniti, 94596
- Reclutamento
- Sunwise Clinical Research, Llc
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Contatto:
- Eken
- Numero di telefono: +41 76 358 88 30
- Email: clinicaltrials@aspeya.com
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-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89118
- Non ancora reclutamento
- M3 Wake Research - Las Vegas Rainbow
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Contatto:
- Eken
- Numero di telefono: +41 76 358 88 30
- Email: clinicaltrials@aspeya.com
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-
Utah
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Salt Lake City, Utah, Stati Uniti, 84124
- Non ancora reclutamento
- Highland Research
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Contatto:
- Eken
- Numero di telefono: +41 76 358 88 30
- Email: clinicaltrials@aspeya.com
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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).
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
|
|
Sperimentale: 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.
|
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).
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of patients with freedom from headache pain at 2 hours post-dose
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of patients with freedom from the most bothersome symptom (MBS) at 2 hours post-dose.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
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Proportion of patients with headache pain relief at 30 minutes post-dose
Lasso di tempo: 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
|
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Proportion of patients who do not use rescue medication within 24 hours post-dose
Lasso di tempo: 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
Lasso di tempo: 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.
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Up to 48 hours post-dose
|
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Number of participants with treatment-emergent adverse events
Lasso di tempo: 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.
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From Screening Visit, through study completion, an average of 16 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
19 maggio 2026
Completamento primario (Stimato)
1 dicembre 2026
Completamento dello studio (Stimato)
1 dicembre 2026
Date di iscrizione allo studio
Primo inviato
27 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
12 giugno 2026
Primo Inserito (Effettivo)
15 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- VFC202-201
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .