Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks

Inclusion Criteria:

• 1. Age ≥18 years old and <65 years old at the time of signing the informed consentform, regardless of gender;

2. Diagnose patients who meet the criteria for the diagnosis of migraine without aurain the third trial version of the International Classification of Headache Diseases (ICHD-Ⅲ(β)) launched by the International Headache Association, and the degree ismoderate or severe;
3. The age of the patient's first migraine attack should be less than 50 years old,and must meet 5 or more migraine attacks without aura or a history of migraine withoutaura ≥ 1 year;
4. The number of moderate or severe migraine attacks ≤6 and ≥1 per month within thefirst 3 months of enrollment, and at least a 48-hour headache interval;
5. Ability to distinguish migraine patients from other types of headaches duringheadache attacks;
6. Female patients who have not had unprotected sex in the 15 days before screening,and patients (regardless of men and women) who have no childbirth plans during thetrial period and within 6 months after the end of the trial;
7. Patients who have the ability to cooperate in observing curative effects andadverse events, and record headache diaries;
8. Before starting any detailed procedures of this study, the patient has the abilityto understand and sign a written informed consent form approved by the ethicscommittee

Exclusion Criteria:

• 1. Patients with migraine with aura, including but not limited to patients withbrainstem migraine with aura and patients with hemiplegic migraine;

2. Patients with average headache time ≥15 days per month in the 3 months before thetest;
3. Patients who have taken painkillers for a long time or overuse of painkillers (takepainkillers for more than 10 days a month for 3 consecutive months);
4. Abnormal renal function: creatinine value> upper limit of normal value;
5. Patients with a history of severe liver disease or patients with significantlyabnormal liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal or total bilirubin (TBIL) )≥1.5 times theupper limit of the normal value;
6. History of major mental and neurological diseases such as depression and epilepsy;
7. Patients who have taken central sedatives for a long time, such as barbiturates andbenzodiazepines, including diazepam, lorazepam, etc.;
8. Patients with severe cardiovascular diseases, such as coronary artery bypasssurgery, or patients with a history of one of the following diseases, including butnot limited to ischemic heart disease, such as angina (including Platts variantangina), Patients with a history of myocardial infarction, arrhythmia (such aspre-excitation syndrome) or disease-related symptoms, signs, or a significant ECGabnormal change;
9. Patients with severe cerebrovascular diseases, including but not limited tocerebral ischemia, cerebral hemorrhage diseases;
10. With severe peripheral vascular disease, such as Raynaud's syndrome;
11. Patients whose blood pressure cannot be effectively controlled after drugtreatment, systolic blood pressure (SBP)>140mmHg or diastolic blood pressure (DBP)>90mmHg;
12. Take ergotamine or ergot derivatives (such as dihydroergotamine or ergonovine) orother 5-HT1 receptor agonists within 7 days before randomization;
13. Patients who have taken MAOI within 14 days before screening;
14. Patients who cannot stop using anticoagulant drugs (such as warfarin) orantiplatelet drugs (such as aspirin) during the trial;
15. Patients who have previously undergone gastric resection or bypass surgery, orpatients with a history of gastrointestinal bleeding, ulcers, or perforation;
16. Patients suffering from sinusitis;
17. Regularly take drugs for preventing headache attacks for more than 2 weeks beforerandomization, including but not limited to flunarizine, topiramate and Chinese patentmedicines with similar effects;
18. Known to triptan drugs, NSAIDs or their pharmaceutical excipients Patients withallergies, or have had aspirin asthma or aspirin triad (aspirin allergy, asthma, andnasal polyps);
19. For patients with alcohol abuse and drug abuse, the standard for alcohol abuse is:drinking an average of more than 28 units per week (a unit of alcohol is equivalent to 250 mL of beer, 125 mL of wine or 20 mL of spirits or enthusiastic alcoholism); Thereare two types of drugs: one is narcotic drugs, such as heroin, marijuana and cannabisresin, opiates and morphine preparations, codeine, etc.; the other is psychotropicdrugs, such as various hallucinogens and tetrahydrocannabinol, central stimulantsDrugs, barbiturates, benzodiazepines, etc.;
20. Patients who are pregnant, breastfeeding, or have a childbearing plan during thestudy period, including female patients of childbearing age who have a positivepregnancy test;
21. Patients who have participated in any other clinical trials within 3 months beforeparticipating in this trial, and who plan to participate in other clinical trials ofother drugs;
22. The patient may not be able to complete the trial due to reasons, or theinvestigator believes that the patient is not suitable to participate in this trial. "