episodic migraine
Conditions
Interventions
NBP group:NBP
Control group:Placebo
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.According to the diagnostic criteria of ICHD-3, there is a history of migraine for at least one year (with or without aura). 2.Male or female subjects aged 18 years or older; 3.The age of onset of migraine is before the age of 50;
Exclusion criteria
Exclusion criteria: 1. Migraine or hemiplegic migraine with brainstem aura; 2. Number of headache (migraine or non-migraine) days per month = 15 days in any month within 3 months prior to the screening visit; 3. Patients with migraine with medication overuse headache; 4. History of HIV infection; 5. Received migraine or head or neck regional intervention/instrumentation (e.g., nerve block or transcranial magnetic stimulation) within 2 months prior to enrollment; 6. Uncontrolled, unstable or recently diagnosed cardiovascular disease (ischemic heart disease, coronary vasospasm and cerebral ischemia). Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack within 6 months (24 weeks) prior to the screening visit; 7. Uncontrolled hypertension or uncontrolled diabetes mellitus. Subjects with a history of hypertension, hypercholesterolemia and/or diabetes mellitus but who are currently in stable controlled condition and have been on a stable dose of medication for at least 3 months (12 weeks) prior to the screening visit may be included in the study; 8. History of gastric or small bowel surgery (including gastric bypass, gastric banding, sleeve gastrectomy, intragastric balloon, etc.), or have diseases that cause malabsorption (such as chronic pancreatitis, ulcerative colitis, etc.); 9. Has a history of Gilbert syndrome or a current diagnosis of Gilbert syndrome or any other active hepatic or biliary disease; 10. Diagnosis of hematologic or solid malignancy within 5 years prior to screening For subjects with a history of localized basal cell carcinoma or squamous cell skin cancer, if confirmed to be cancer-free before the screening visit in this study, they may participate in this study; 11. Previous or current history of any unstable medical disease (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, cancer) that, in the opinion of the investigator, would increase the risk of important adverse events in the subject or interfere with the safety/efficacy assessment during the course of the trial; 12. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex local pain syndrome); 13. Has other pain syndromes (including trigeminal neuralgia), psychiatric disorders, dementia, or significant neurological diseases (other than migraine) that, in the opinion of the investigator, may interfere with the study assessments; 14. Current or prior diagnosis of schizophrenia, bipolar disorder, or borderline personality disorder; 15. Have had a depressive episode in the past 12 months, or need to use more than 1 standard treatment medication per day for their depressive disorder or anxiety disorder. For medications (up to 1) for the treatment of depressive disorder or anxiety disorder, treatment must be maintained at a stable dose for at least 3 months prior to the screening visit and treatment must be continued until the end of the study; 16. History of alcohol or drug abuse, treatment history, or evidence within 12 months (48 weeks) prior to the Screening Visit, or any significant substance abuse history consistent with the DSM-5 between 12 months (48 weeks) prior to the Screening Visit and the end of the double-blind treatment period; 17. If the subject has a positive screening result for addiction drugs, and the investigator believes that the result is medically significant and will affect the safety of the subject or the interpretation o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in monthly migraine days compared with the observation period throughout the double-blind treatment period (weeks 1~12).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the number of days per month of use of any acute headache medication relative to the observation period throughout the double-blind treatment period; | — |
Countries
China
Contacts
Public ContactJingxi-Ma
Chongqing General Hospital
Outcome results
None listed