A Phase II Study of NB001 for Acute Migraine Treatment (Channel)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: One tablet of NB001 plus three tablets of placebo; Drug: Two tablets of NB001 plus two tablets of placebo; Drug: Four tablets of NB001; Drug: Four tablets of placebo

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhao Dong, Doctor; Phone Number: +8618910685535; Email: dong_zhaozhao@126.com
• Study Contact Backup: Name: Mingjie Zhang, Doctor; Phone Number: +8618910276582; Email: mjzhangnk@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient is aged ≥18 and ≤65 years at the Screening Visit, of either sex.
2. 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.
3. 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.
4. 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.
5. According to the investigator's judgment, the patient's untreated or unsuccessfully treated migraine attacks typically last 4 to 72 hours.
6. The patient is able to read and understand the Informed Consent Form, and signed the Informed Consent Form.
7. Women of childbearing potential and male participants must practice strict contraception from screening until 30 days after the last dose.
8. The patient is capable of adequately understanding and completing the study-related scales and using the electronic patient-reported outcome software.

Exclusion Criteria:

1. 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.
2. The patient is unable to distinguish migraine attacks from tension-type headaches or other headaches.
3. 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.
4. The patient has special types of migraine, such as hemiplegic migraine or migraine with brainstem aura.
5. The patient has other complex pain syndromes, complex psychiatric disorders, dementia, epilepsy, or other significant neurological disorders as judged by the investigator.
6. The patient has a chronic, non-headache pain condition requiring daily pain medication.
7. The patient has clinically significant cardiovascular, cerebrovascular, hematological, endocrine, pulmonary, renal, hepatic, gastrointestinal, psychiatric, or neurological disorders.
8. 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.
9. 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.
10. The patient has active peptic ulcers, chronic gastrointestinal inflammation, or severe hemorrhoids (Grade III-IV internal hemorrhoids or bleeding external hemorrhoids).
11. 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.
12. 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.
13. The patient has a 12-lead ECG result at the Screening Visit showing QTcF >450 msec in males or >470 msec in females.
14. The patient has a suspected or confirmed history of alcohol or drug abuse.
15. The patient has a positive pregnancy test, is pregnant or breastfeeding, or is planning to become pregnant.
16. The patient has participated in another clinical trial within 1 month prior to the Screening Visit.
17. Subjects deemed by the investigator as inappropriate for enrollment in this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One tablet of NB001 plus three tablets of placebo	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.
Experimental: Two tablets of NB001 plus two tablets of placebo	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.
Experimental: Four tablets of NB001	Drug: Four tablets of NB001; Take 4 tablets of NB001 at the onset of moderate-to-severe acute migraine.
Placebo Comparator: Four tablets of placebo	Drug: Four tablets of placebo; Take 4 tablets of placebo at the onset of moderate-to-severe acute migraine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects with Pain Relief from Baseline at 2 Hours Post-Dose	Proportion of subjects with pain relief (defined as reduction from moderate/severe migraine-like headache at baseline [pre-dose] to mild headache or no headache) at 2 hours post-dose.	2 hours post-dose
Restoration of Normal Function at 2 Hours	Proportion of subjects with restoration of normal function (as reported by the Functional Disability Scale) at 2 hours post-dose.	2 hours post-dose.
Proportion of subjects using rescue medication within 24 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	Proportion of subjects with sustained pain relief (defined as pain relief at 2 hours post-dose, no use of rescue medication, and no moderate/severe headache between 2 and 24 hours) 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.	Proportion of subjects with sustained pain relief between 2 and 48 hours post-dose.	Between 2 and 48 hours post-dose.
Proportion of subjects with sustained pain-free status between 2 and 24 Hours Post-Dose	Proportion of subjects with sustained pain-free status (defined as pain-free at 2 hours post-dose, no use of rescue medication, and no mild/moderate/severe headache between 2 and 24 hours) between 2 and 24 hours post-dose.	Between 2 and 24 Hours Post-Dose
Proportion of subjects with sustained pain-free status between 2 and 48 hours post-dose.	Proportion of subjects with sustained pain-free status between 2 and 48 hours post-dose.	Between 2 and 48 hours post-dose.
Proportion of subjects with pain relief at 15, 30, 45, 60, and 90 minutes post-dose.	Proportion of subjects with pain relief at 15, 30, 45, 60, and 90 minutes post-dose.	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.	Proportion of subjects without MBS (Migraine-associated Symptoms)at 15, 30, 45, 60, and 90 minutes post-dose.	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.	Proportion of subjects with pain-free status at 15, 30, 45, 60, and 90 minutes post-dose.	At 15, 30, 45, 60, and 90 minutes post-dose.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion with pain free at each post-dose time points.	Proportion of subjects with pain free at all recorded time points after dosing;	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.	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.	Proportion of subjects with no MBS (migraine-associated symptoms) 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 of subjects with restoration of normal function at all post-dose time points.	Proportion of subjects with restoration of normal function at all 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
Resolution of Baseline Phonophobia at Each Post-Dose Time Point	Among subjects who reported phonophobia as an MBS (migraine-associated symptoms)at baseline, the percentage of subjects with resolution of this symptom at each post-dose time point.	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 of subjects with resolution of baseline photophobia at each post-dose time point	Among subjects who reported photophobia as an MBS (migraine-associated symptoms)a at baseline, the percentage of subjects with resolution of this symptom at each post-dose time point.	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 of subjects with resolution of baseline nausea at each post-dose time point.	Among subjects who reported nausea as an MBS before administration, the proportion of subjects with resolution of this symptom at each time point after administration.	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 of subjects with sustained absence of MBS from 2 to 24 hours post-dose.	Proportion of subjects with sustained absence of MBS from 2 to 24 hours post-dose.	From 2 to 24 hours post-dose.
Proportion of subjects with sustained absence of MBS from 2 to 48 hours post-dose.	Proportion of subjects with sustained absence of MBS from 2 to 48 hours post-dose.	From 2 to 48 hours post-dose.
Proportion of subjects with sustained normal functional ability from 2 to 24 hours post-dose.	Proportion of subjects with sustained normal functional ability from 2 to 24 hours post-dose.	From 2 to 24 hours post-dose.
Proportion of subjects with sustained normal functional ability from 2 to 48 hours post-dose.	Proportion of subjects with sustained normal functional ability from 2 to 48 hours post-dose.	From 2 to 48 hours post-dose.
Proportion of subjects with overall improvement at all recorded post-dose time points and Patient Global Impression of Change (PGI-C) scores.	Proportion of subjects with overall improvement at all recorded post-dose time points and Patient Global Impression of Change (PGI-C) scores.	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; 5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol
• Other Study ID Numbers: NB001-02-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No