migraine
Conditions
Interventions
Group A:Tizanidine hydrochloride 1mg tid, 1mg/ tablet
Group B:Tizanidine hydrochloride 2mg tid, 2mg/ tablet
Group C:Placebo 1 tablet tid
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria to participate in the study: 1) Age 18 ~ 65 years old (including both ends of the value); 2) According to ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), Subjects were diagnosed with migraine without aura and/or migraine with aura and had a history of at least 1 year; 3) The age of onset of the first migraine is less than 50 years old; 4) Migraine days =4 days/month and < 15 days/month in the 3 months prior to entering the screening period (refer to 7.1.1 definition of migraine days); 5) Within three months prior to entering the screening period, the number of days of headache (including migraine and other types of headache) per month is less than 15 days (refer to the definition of headache days in 7.1.2); 6) Willing to take effective contraceptive measures during the period of participation in this trial and within 28 days after the end of the last dose; 7) Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign informed consent in person to agree to enter the baseline period. The following criteria are required during the baseline period to enter a randomized, double-blind, placebo-controlled drug trial: 8) Migraine days =4 days and < 14 days during the 4-week baseline period (as assessed in Annex 14). Electronic headache diary); 9) Headache days < 14 days within 4 weeks of baseline period; 10) At least 80% of the electronic diary was completed within 4 weeks of the baseline period (at least 23 days of the baseline period of 28 days), and the investigator considered the subject to be able to read, understand, and complete the study questionnaire and headache diary; 11) Understand and abide by the research procedures and methods, voluntarily participate in this study, and sign informed consent in person, agreeing to enter the randomized double-blind placebo-controlled drug trial.
Exclusion criteria
Exclusion criteria: Subjects with any of the following cannot participate in the study: 1) The subject is diagnosed with probable migraine according to the International Classification of Headache Disorders, Third Edition (ICHD-3, 2018); 2) Current and previous diagnoses of primary headache, secondary headache, or painful cranial neuropathy other than migraine (diagnostic criteria as defined by ICHD-3, 2018); 3) More than 2 of the following 7 drugs used in the past are ineffective after adequate treatment, and these drugs are as follows: • Category 1: divalproic acid, sodium valproate • Type 2: Topiramate • Class 3: beta-receptor blockers (e.g. Atenolol, Bisoprolol, Metoprolol, Nadolol, Nebilolol, indololol, Propranolol, Timolol) Class 4: Tricyclic antidepressants (e.g., amitriptyline, nortriptyline, protiline) • Class 5: Serotonin norepinephrine reuptake inhibitors (e.g. Venlafaxine, norvenlafaxine, Duloxetine, Minapram) • Category 6: Flunarizine, verapamil • Category 7: Lisinopril, Candesartan Class 8: Drugs that act on the CGRP pathway (monoclonal antibodies and Gepants) The definition of ineffective treatment: frequency, duration, and severity of headache after 6 weeks of administration of the above drugs The degree did not decrease. The following conditions do not constitute ineffective treatment: • Lack of sustained response to medication • Cannot tolerate the dose of the drug 4) Use of prohibited drugs, proprietary Chinese medicines, Chinese herbs, instruments or therapies in the 2 months prior to or during the baseline period (see 5.7.2 Prohibited drugs/treatments); 5) Patients who received therapeutic or cosmetic botox injections (e.g. Dysport®, Botox ®, Xeomin®, Myobloc® and JeuveauTM) to the head, face or neck within 4 months prior to screening and during the study period; 6) Concurrent use of 2 or more medications that may have a preventive effect on migraine within 2 months prior to the start of the baseline period or during the baseline period (see Annex 3 for details). List of migraine prophylactic drugs) (if only 1 prophylactic drug is used, the dose must remain stable for 2 months prior to baseline and throughout the study period); 7) The following conditions occurred within 2 months prior to the start of the baseline period: • Take ergotamines or triptans for =10 days per month, or • Use of nonsteroidal anti-inflammatory drugs (NSAID) for =15 days per month, non-steroidal anti-inflammatory drug combinations for =10 days, or • Take opioid or barbiturate analgesics for =4 days per month 8) Subjects are expected to use the following prohibited drugs during double-blind treatment: Fluvoxamine, ciprofloxacin (cytochrome oxidase P450IA2 inhibitor), fluoroquinolones, Zyliutone, antiarrhythmic drugs (amiodarone, mexiletine, propafenone and verapamil), cimetidine, Famotidine, acyclovir, ticlopidine, metoprolol, propranolol and other beta blockers, clonidine and other a2 - Adrenergic agonists, proprietary Chinese medicines, Chinese herbs, devices or regimens (see 5.7.2 Prohibited Drugs/Treatments for details) 9) The subject has active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, facial pain, etc.); 10) The subjects have a history of mental illness (such as schizophrenia or bipolar disorder) or 7.2.6 Patient Health Questionnaire (PHQ-9) score =15 points; If the subject has a history of anxiety or depression (PHQ-9 score < 15) and takes no more than one psychotropic drug (other than prohibited drugs), the subject is admitted to d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean number of migraine days per 4 weeks over the 12-week treatment period from baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the mean frequency of headache attacks every 4 weeks during the 12-week treatment period;;Change from baseline in the mean number of moderate/severe headache days per 4 weeks during the 12-week treatment period;;Proportion of subjects with at least a 50%, 75%, and 100% reduction in the average number of migraine attack days per 4 weeks during the 12-week treatment period;;Changes from baseline in the mean dose and frequency of medication used for acute episodes every 4 weeks during the 12-week treatment period;;Change in peak headache intensity from baseline every 4 weeks during the 12-week treatment period;;Change in mean headache intensity from baseline every 4 weeks during the 12-week treatment period;; | — |
Countries
China
Contacts
Public ContactLiu Kaiming
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed