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

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

‣ 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.

Locations
Other Locations
China
Dongyang People's Hospital
NOT_YET_RECRUITING
Dongyang
Guangdong 999 Brain Hospital
NOT_YET_RECRUITING
Guangzhou
Kaiming Liu
RECRUITING
Hangzhou
Tongde Hospital of Zhejiang Province
NOT_YET_RECRUITING
Hangzhou
Xinhua Hospital of Zhejiang Province
NOT_YET_RECRUITING
Hangzhou
The First People's Hospital of Huzhou City
NOT_YET_RECRUITING
Huzhou
Jinhua People's Hospital
NOT_YET_RECRUITING
Jinhua
Jinjiang Municipal Hospital
NOT_YET_RECRUITING
Jinjiang
Medical Community of Linhai First People's Hospital
NOT_YET_RECRUITING
Linhai
The First People's Hospital of Jiande
NOT_YET_RECRUITING
Meicheng
The Second Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Quanzhou
Shenzhen People's Hospital
NOT_YET_RECRUITING
Shenzhen
Shenzhen University General Hospital
NOT_YET_RECRUITING
Shenzhen
Tiantai People's Hospital of Zhejiang Province
NOT_YET_RECRUITING
Tiantai
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Yiwu
The Second People's Hospital of Yuhuan
NOT_YET_RECRUITING
Yuhuan
The First People's Hospital of Zhaoqing
NOT_YET_RECRUITING
Zhaoqing
People's Hospital Affiliated to Jiangsu University/Zhenjiang First People's Hospital
NOT_YET_RECRUITING
Zhenjiang
Contact Information
Primary
Kaiming Liu, MD & PHD
2314411@zju.edu.cn
+8615068862055
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 288
Treatments
Experimental: Anisodine Hydrobromide
Participants in this group took oral Anisodine Hydrobromide tablets 1 mg bid for 12 consecutive weeks and were followed up for 12 weeks.
Placebo_comparator: Anisodine Hydrobromide Placebo
Participants in this group took oral Anisodine Hydrobromide placebo tablets 1 mg bid for 12 consecutive weeks and were followed up for 12 weeks.
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov