Not Yet RecruitingPhase 2

A Phase II Study of NB001 for Acute Migraine Treatment

120 participantsStarted 2026-04-20

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

Primary Outcome Measure

Timeframe: 2 hours post-dose

Trial details

NCT IDNCT07577050

SponsorChinese PLA General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Zhao Dong, Doctor

+8618910685535 dong_zhaozhao@126.com

View on ClinicalTrials.gov More Migraine trials