A Phase II Study of NB001 for Acute Migraine Treatment

Official title

A Phase II, Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NB001 for the Acute Treatment of Migraine

Overview

The goal of this observational study is to Evaluate the Efficacy and Safety of NB001 for the Acute Treatment of Migraine in Adult patients diagnosed with migraine.

Interventions

• Drug One tablet of NB001 plus three tablets of placebo
  Take 1 tablet of NB001 + 3 tablets of placebo at the onset of moderate-to-severe acute migraine.
• Drug Two tablets of NB001 plus two tablets of placebo
  Take 2 tablets of NB001 plus 2 tablets of placebo at the onset of moderate-to-severe acute migraine.
• Drug Four tablets of NB001
  Take 4 tablets of NB001 at the onset of moderate-to-severe acute migraine.
• Drug Four tablets of placebo
  Take 4 tablets of placebo at the onset of moderate-to-severe acute migraine.

Primary outcome measures

• Primary Outcome Measure [Time frame: 2 hours post-dose]

Secondary outcome measures (10)

• Proportion of Subjects with Pain Relief from Baseline at 2 Hours Post-Dose [Time frame: 2 hours post-dose]
• Restoration of Normal Function at 2 Hours [Time frame: 2 hours post-dose.]
• Proportion of subjects using rescue medication within 24 hours post-dose. [Time frame: Within 24 hours post-dose.]
• Proportion of subjects with sustained pain relief between 2 and 24 Hours Post-Dose [Time frame: Between 2 and 24 hours post-dose.]
• Proportion of subjects with sustained pain relief between 2 and 48 hours post-dose. [Time frame: Between 2 and 48 hours post-dose.]
• Proportion of subjects with sustained pain-free status between 2 and 24 Hours Post-Dose [Time frame: Between 2 and 24 Hours Post-Dose]
• Proportion of subjects with sustained pain-free status between 2 and 48 hours post-dose. [Time frame: Between 2 and 48 hours post-dose.]
• Proportion of subjects with pain relief at 15, 30, 45, 60, and 90 minutes post-dose. [Time frame: At 15, 30, 45, 60, and 90 minutes post-dose.]
• Proportion of subjects without MBS (Migraine-associated Symptoms)at 15, 30, 45, 60, and 90 minutes post-dose. [Time frame: At 15, 30, 45, 60, and 90 minutes post-dose.]
• Proportion of subjects with pain-free status at 15, 30, 45, 60, and 90 minutes post-dose. [Time frame: At 15, 30, 45, 60, and 90 minutes post-dose.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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 is unable to distinguish migraine attacks from tension-type headaches or other headaches.
• 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 special types of migraine, such as hemiplegic migraine or migraine with brainstem aura.
• 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 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 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 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.
• 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 suspected or confirmed history of alcohol or drug abuse.
• The patient has a positive pregnancy test, is pregnant or breastfeeding, or is planning to become pregnant.
• The patient has participated in another clinical trial within 1 month prior to the Screening Visit.
• Subjects deemed by the investigator as inappropriate for enrollment in this clinical study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07577050 · NB001-02-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗