A Phase II Study of NB001 for Acute Migraine Treatment

Prior treatment

• The patient has a severe allergic constitution, or has known or suspected allergies to the investigational product or its excipients as judged by the investigator.
• The patient has an average history of ≥15 headache days per month in the 3 months prior to the Screening Visit, or currently meets the ICHD-3 diagnostic criteria for chronic migraine, as judged by the investigator.
• The patient has any prior history of gastrointestinal disease that may affect the absorption or metabolism of the study drug, or has a recent history of diarrhea.
• The patient has participated in another clinical trial within 1 month prior to the Screening Visit.

Other illness

• The patient has other complex pain syndromes, complex psychiatric disorders, dementia, epilepsy, or other significant neurological disorders as judged by the investigator.
• The patient has a chronic, non-headache pain condition requiring daily pain medication.
• The patient has clinically significant cardiovascular, cerebrovascular, hematological, endocrine, pulmonary, renal, hepatic, gastrointestinal, psychiatric, or neurological disorders.
• The patient has a history of malignancy within 5 years prior to the Screening Visit, with the exception of adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
• The patient has active peptic ulcers, chronic gastrointestinal inflammation, or severe hemorrhoids (Grade III-IV internal hemorrhoids or bleeding external hemorrhoids).
• The patient has tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, Treponema pallidum antibodies (TPHA), or human immunodeficiency virus (HIV) antibodies at the Screening Visit.
• The patient has a suspected or confirmed history of alcohol or drug abuse.

Lab values

• The patient has hepatic dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 × upper limit of normal; estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² (calculated using the simplified MDRD formula); or creatine kinase \>2.0 × ULN.

Other

• The patient is unable to distinguish migraine attacks from tension-type headaches or other headaches.
• The patient has special types of migraine, such as hemiplegic migraine or migraine with brainstem aura.
• The patient has a 12-lead ECG result at the Screening Visit showing QTcF \>450 msec in males or \>470 msec in females.
• The patient has a positive pregnancy test, is pregnant or breastfeeding, or is planning to become pregnant.
• Subjects deemed by the investigator as inappropriate for enrollment in this clinical study.

• The patient is aged ≥18 and ≤65 years at the Screening Visit, of either sex.
• The patient has a diagnosis of migraine with aura or migraine without aura as defined by the ICHD-3 criteria confirmed at the Screening Visit.
• The patient has had an onset of migraine at \<50 years of age, with a history of migraine (with or without aura) of at least 1 year prior to the Screening Visit.
• According to the investigator's judgment, the patient has had 2 to 8 moderate or severe migraine attacks per month in the 3 months prior to the Screening Visit.
• According to the investigator's judgment, the patient's untreated or unsuccessfully treated migraine attacks typically last 4 to 72 hours.
• The patient is able to read and understand the Informed Consent Form, and signed the Informed Consent Form.
• Women of childbearing potential and male participants must practice strict contraception from screening until 30 days after the last dose.
• The patient is capable of adequately understanding and completing the study-related scales and using the electronic patient-reported outcome software.