A Phase II Study of NB001 for Acute Migraine Treatment

NCT07577050 | Not Yet Recruiting Phase 2

• 1 other identifier: NB001-02-002
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  1.Proportion of subjects with no pain at 2 hours post-dose; 2.proportion of subjects with no most bothersome symptom (MBS) at 2 hours post-dose.

  2 hours post-dose

Secondary Outcomes (10)

• Proportion of Subjects with Pain Relief from Baseline at 2 Hours Post-Dose

  2 hours post-dose

• Restoration of Normal Function at 2 Hours

  2 hours post-dose.

• Proportion of subjects using rescue medication within 24 hours post-dose.

  Within 24 hours post-dose.

• Proportion of subjects with sustained pain relief between 2 and 24 Hours Post-Dose

  Between 2 and 24 hours post-dose.

• Proportion of subjects with sustained pain relief between 2 and 48 hours post-dose.

  Between 2 and 48 hours post-dose.

Other Outcomes (12)

• Proportion with pain free at each post-dose time points.

  At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose

• Proportion with pain relief at each post-dose time points.

  At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose

• Proportion with absence of MBS at each post-dose time points.

  At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 24 hours, 48 hours post-dose

Study Arms (4)

One tablet of NB001 plus three tablets of placebo

EXPERIMENTAL

Drug: One tablet of NB001 plus three tablets of placebo

Two tablets of NB001 plus two tablets of placebo

EXPERIMENTAL

Drug: Two tablets of NB001 plus two tablets of placebo

Four tablets of NB001

EXPERIMENTAL

Drug: Four tablets of NB001

Four tablets of placebo

PLACEBO COMPARATOR

Drug: Four tablets of placebo

Interventions

Four tablets of NB001 DRUG

Take 4 tablets of NB001 at the onset of moderate-to-severe acute migraine.

Four tablets of NB001

One tablet of NB001 plus three tablets of placebo DRUG

Take 1 tablet of NB001 + 3 tablets of placebo at the onset of moderate-to-severe acute migraine.

One tablet of NB001 plus three tablets of placebo

Two tablets of NB001 plus two tablets of placebo DRUG

Take 2 tablets of NB001 plus 2 tablets of placebo at the onset of moderate-to-severe acute migraine.

Two tablets of NB001 plus two tablets of placebo

Four tablets of placebo DRUG

Take 4 tablets of placebo at the onset of moderate-to-severe acute migraine.

Four tablets of placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Hebei Provincial People's Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Nanjing Brain Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Xiangya Hospital of Central South University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• 940 Hospital of the People's Liberation Army Joint Logistic Support Force: collaborator
• The First Hospital of Jilin University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Peking Union Medical College Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• The Second Affiliated Hospital of the Air Force Medical University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Jiangsu Province Nanjing Brain Hospital: collaborator
• People's Hospital of Wuhan University: collaborator
• The Second Affiliated Hospital of Army Medical University: collaborator
• Renmin Hospital of Wuhan University: collaborator

MeSH Terms

Conditions

Migraine Disorders

Interventions

5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Zhao Dong, Doctor

CONTACT

+8618910685535; dong_zhaozhao@126.com

Mingjie Zhang, Doctor

CONTACT

+8618910276582; mjzhangnk@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: May 11, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05