Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults

Официальное название

Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase II Trial of PRT-064040 Nasal Spray for the Acute Treatment of Migraine

Обзор

The purpose of this study is to learn about the efficacy and safety of PRT-064040 Nasal Spray versus placebo in the acute treatment of moderate or severe migraine.

Вмешательства

• Препарат PRT-064040 nasal spray
  A single dose of PRT-064040 nasal spray
• Препарат Placebo
  A single dose of placebo matched to PRT-064040 nasal spray

Первичные конечные точки

• Percentage of Participants With Freedom From Pain at 2 Hours Post-dose [Срок оценки: 2 hours post-dose]
• Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose [Срок оценки: 2 hours post-dose]

Вторичные конечные точки (12)

• Percentage of Participants With Pain Relief at 15 Minutes Post-dose [Срок оценки: 15 minutes post-dose]
• Percentage of Participants With Pain Relief at 30 Minutes Post-dose [Срок оценки: 30 minutes post-dose]
• Percentage of Participants With Pain Relief at 60 Minutes Post-dose [Срок оценки: 60 minutes post-dose]
• Percentage of Participants With Pain Relief at 2 Hours Post-dose [Срок оценки: 2 hours post-dose]
• Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose [Срок оценки: 2 hours post-dose]
• Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose [Срок оценки: From 2 to 24 hours post-dose]
• Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose [Срок оценки: From 2 to 48 hours post-dose]
• Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose [Срок оценки: 30 minutes post-dose]
• Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose [Срок оценки: 60 minutes post-dose]
• Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose [Срок оценки: 2 hours post-dose]
• Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose [Срок оценки: 2 hours post-dose]
• Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose [Срок оценки: 2 hours post-dose]

Критерии участия

Критерии включения

Критерии включения

• Male and female participants aged 18-75 years (inclusive);
• BMI < 35 kg/m²;
• Participant has at least 1-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition;
• Age at first migraine onset < 50 years;
• Migraine attacks, on average, lasting about 4-72 hours if untreated or treatment-resistant;
• 2-8 attacks of moderate to severe intensity per month within the last 3 months；
• Less than 15 days with headache (migraine or non-migraine) per month within the last 3 months；
• Participants on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change until the EOT visit;
• Patients diagnosed with chronic migraine who, owing to stable preventive therapy, have < 15 headache days and 2-8 attacks of moderate to severe intensity per month in the 3 months before screening, and who meet all other entry criteria, may be enrolled;
• Able to comprehend and complete study questionnaires with electronic patient-reported outcome (e-PRO) application.

Критерии исключения

Критерии исключения

• Participant with history of migraine with brainstem aura, retinal migraine, or hemiplegic migraine.
• Participant with evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cardiometabolic disease, or prior history thereof, including:

• Ischemic heart disease, coronary vasospasm, or cerebral ischemia diagnosed within 6 months before screening;
• Previous stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, cardiac surgery, or percutaneous coronary intervention;
• Abnormal 12-lead ECG at screening;
• Poorly controlled diabetes mellitus or hypertension;
• Poorly controlled or severe peripheral vascular disease.
• Participant with any nasal structural abnormality, mucosal lesion, or disorder that could interfere with intranasal drug absorption.
• Participant with dysgeusia, hypogeusia, or related taste disorders.
• Participant with acute or chronic pain syndromes, or any other pain that in the investigator's opinion could confound study assessments.
• Participant with history of regular use of ergotamine or triptans ≥ 10 days per month for ≥ 3 months; or regular use of non-narcotic analgesics (e.g., acetaminophen, NSAIDs, gabapentin) ≥ 15 days per month for ≥ 3 months.
• Clinically relevant abnormal findings in hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or HIV antibody tests at screening.
• Participant with history of alcohol or drug abuse within 1 year before screening, or positive urine drug screen at screening.
• Pregnant or lactating women, or positive pregnancy test at screening.
• Participant with known hypersensitivity to the investigational product or any of its excipients, or history of significant allergic reactions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Medical Center of PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07304518 · BT-PRT-064-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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