A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety, And Tolerability Of Anisodine Hydrobromide For The Preventive Treatment Of Episodic Migraine
In this study,288 adult migraine patients aged 18-65 years (diagnosed with migraine without aura and/or migraine with aura, with at least a 1-year history)will be collected to evaluate the efficacy, safety and tolerability of Anisodine Hydrobromide in preventing migraine attacks in episodic migraine in adults.
‣ Subjects must meet all of the following inclusion criteria to participate in this study.
• The age at entry for trails involving adult subjects is 18-65 years (including both ends);
• According to ICHD-3(Headache Classification Committee of the International Headache Society,2018), individuals should be diagnosed with migraine without aura and/or migraine with aura, and should have a history of at least 1 year;
• The age at first migraine onset should be \<50 years;
• Migraine attacks ≥ 4 days/month and \< 15 days/month within 3 months prior to screening period (Refer to the definition of migraine days);
• Within 3 months before entering the screening period, the number of headache (including migraine and other types of headache) attack days per month is less than 15 days/month (Refer to the definition of headache days);
• Be willing to take effective contraceptive measures during the period of participating in this experiment and within 28 days after the last time taking investigational product;
• Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the baseline period.
• The following criteria must be met during the baseline period to be eligible for entering the randomized, double-blind, placebo-controlled trial of the drug:
• Migraine days ≥4 and \<14 days within 4 weeks of baseline period(Evaluation based on the Annex 14.-Electronic Headache Diary);
• Headache days \< 14 days within 4 weeks of baseline period;
⁃ Completion of at least 80% of the electronic diary within 4 weeks of the baseline period(Within 28 days of the baseline period, the electronic diary has been completed for at least 23 days), and the investigator believes that the subject is able to read, understand, and complete the study questionnaire and headache diary;
⁃ Understand and abide by the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent in writing, agreeing to enter the randomized, double-blind, placebo-controlled trials of the drug.