migraine
Conditions
Interventions
migraine:Tizanidine hydrochloride tablets(1mg,TID)
migraine:Tizanidine hydrochloride tablets (1mg in the morning and at noon, 2mg in the evening)
migraine:Tizanidine hydrochloride tablets(2mg,TID)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In accordance with the diagnostic criteria for migraine with aura and without aura (ICHD-III) of the international society of headache classification (2018) and the standard of preventive treatment of migraine in China's guidelines for prevention and treatment of migraine in 2016; 2. Cranial CT or MRI was negative, and neurologic examination was negative; 3. They are 18-65 years old, male and female; 4. The subjects could accurately understand the researcher's instructions and complete the headache diary independently or with the help of their family members; 5. Voluntary written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled hypertension were treated with ß - blockers or a - agonists; 2. Severe infection occurred in the past 6 months; 3. Patients with severe cardiovascular disease (severe heart failure, atrial fibrillation, after cardiovascular interventional surgery), cerebrovascular disease (stroke, cerebrovascular malformation), central nervous system infection, intracranial space occupying lesions, or brain trauma and other diseases; 4. Patients with severe primary diseases of liver and kidney hematopoietic system (transaminase exceeds 3 times the upper limit of normal value, total bilirubin and creatinine exceed 1.5 times the upper limit of normal value, or creatinine clearance rate<45ml/min); 5. Patients with cervical spondylosis, otogenic, rhinogenic, odontogenic, and other secondary headache; 6. Migraine belongs to drug overuse headache and other special types of migraine (such as ophthalmoplegia, hemiplegia, etc.); 7. In recent 3 months, he has taken other drugs to prevent migraine attack systematically; 8. Combination of alcohol or other drug abusers; 9. Patients with severe mental illness, depression, or anxiety disorder; 10. Participants in other clinical trials during the period of participating in this trial; 11. Allergy to the drug or similar drugs; 12. Planned pregnancy, pregnancy, and lactation women; 13. The investigator judged that it was not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tizanidine concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Population pharmacokinetic model;Gene polymorphism;Blood safety index;Headache impact test;Hamilton Anxiety Scale;Hamilton Depression Scale;Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital, Sichuan University
Outcome results
None listed