A Phase II Study of NB001 for Acute Migraine Treatment

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.

Conditions

• 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.

Sponsors & Collaborators

• Hebei Provincial People's Hospital

  collaborator UNKNOWN

• Guangdong Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Nanjing Brain Hospital

  collaborator UNKNOWN

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• 940 Hospital of the People's Liberation Army Joint Logistic Support Force

  collaborator OTHER

• People's Hospital of Wuhan University

  collaborator UNKNOWN

• The First Hospital of Jilin University

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The Second Affiliated Hospital of Army Medical University

  collaborator UNKNOWN

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• The Second Affiliated Hospital of the Air Force Medical University

  collaborator UNKNOWN

• Fujian Medical University Union Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Jiangsu Province Nanjing Brain Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-20

Primary Completion

2026-09-30

Completion

2026-12-31