MigrainePhase 2ChannelNCT07577050
A Phase II Study of NB001 for Acute Migraine Treatment
A Phase 2 study testing Four tablets of NB001 in people with Migraine, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Four tablets of NB001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- One tablet of NB001 plus three tablets of placebo, Two tablets of NB001 plus two tablets of placebo, Four tablets of NB001, Four tablets of placebo
- Keywords
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One tablet of NB001 plus three tablets of placeboDrug
Take 1 tablet of NB001 + 3 tablets of placebo at the onset of moderate-to-severe acute migraine.
Two tablets of NB001 plus two tablets of placeboDrug
Take 2 tablets of NB001 plus 2 tablets of placebo at the onset of moderate-to-severe acute migraine.
Four tablets of NB001Drug
Take 4 tablets of NB001 at the onset of moderate-to-severe acute migraine.
Four tablets of placeboDrug
Take 4 tablets of placebo at the onset of moderate-to-severe acute migraine.
| Study group | Role | What they receive |
|---|---|---|
| One tablet of NB001 plus three tablets of placebo | Experimental | Not described Receives: Drug: One tablet of NB001 plus three tablets of placebo |
| Two tablets of NB001 plus two tablets of placebo | Experimental | Not described Receives: Drug: Two tablets of NB001 plus two tablets of placebo |
| Four tablets of NB001 | Experimental | Not described Receives: Drug: Four tablets of NB001 |
| Four tablets of placebo | Placebo comparator | Not described Receives: Drug: Four tablets of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours post-dose
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 15, 30, 45, 60, and 90 minutes post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start20 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Provincial People's Hospital, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Xiamen University, Nanjing Brain Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xiangya Hospital of Central South University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Chongqing Medical University, 940 Hospital of the People's Liberation Army Joint Logistic Support Force, People's Hospital of Wuhan University, The First Hospital of Jilin University, The First Affiliated Hospital of Dalian Medical University, Peking Union Medical College Hospital, Shandong Provincial Hospital, Second Affiliated Hospital of Army Medical University, Second Xiangya Hospital of Central South University, The Second Affiliated Hospital of Air Force Military Medical University, Fujian Medical University Union Hospital, Renmin Hospital of Wuhan University, Jiangsu Province Nanjing Brain Hospital
- Responsible party
- Principal investigator, Zhao Dong, MD, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577050
- Sponsor's protocol ID
- NB001-02-002
- Acronym
- Channel
- Status last verified
- May 2026
- First submitted
- 7 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07577050
- Acronym / sponsor ID
- Channel / NB001-02-002
- Conditions
- Migraine
- Keywords
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Hebei Provincial People's Hospital, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Xiamen University, Nanjing Brain Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xiangya Hospital of Central South University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Chongqing Medical University, 940 Hospital of the People's Liberation Army Joint Logistic Support Force, People's Hospital of Wuhan University, The First Hospital of Jilin University, The First Affiliated Hospital of Dalian Medical University, Peking Union Medical College Hospital, Shandong Provincial Hospital, Second Affiliated Hospital of Army Medical University, Second Xiangya Hospital of Central South University, The Second Affiliated Hospital of Air Force Military Medical University, Fujian Medical University Union Hospital, Renmin Hospital of Wuhan University, Jiangsu Province Nanjing Brain Hospital
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One tablet of NB001 plus three tablets of placeboTake 1 tablet of NB001 + 3 tablets of placebo at the onset of moderate-to-severe acute migraine. | Drug | One tablet of NB001 plus three tablets of placebo |
| Two tablets of NB001 plus two tablets of placeboTake 2 tablets of NB001 plus 2 tablets of placebo at the onset of moderate-to-severe acute migraine. | Drug | Two tablets of NB001 plus two tablets of placebo |
| Four tablets of NB001Take 4 tablets of NB001 at the onset of moderate-to-severe acute migraine. | Drug | Four tablets of NB001 |
| Four tablets of placeboTake 4 tablets of placebo at the onset of moderate-to-severe acute migraine. | Drug | Four tablets of placebo |
Primary outcome
Primary Outcome Measure
Time frame: 2 hours post-dose
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.
10 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Four tablets of NB001 in people with Migraine, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Dong, Doctor (+8618910685535, dong_zhaozhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 2 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.