Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Migraine Without Aura
Migraine With Aura
Anisodine Hydrobromide
Anisodine Hydrobromide placebo
PHASE3
1. Research contents: 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. 2. Research target: To evaluate the efficacy, safety and tolerability of oral Anisodine Hydrobromide in preventing migraine attacks in episodic migraine in adults, we used the change from baseline in migraine days per 4 weeks during the 12-week treatment period as the primary endpoint. 3. Research design: This study uses a multicenter, randomized, double-blind, placebo-controlled, parallel design and plans to enroll 288 adult patients with episodic migraine. A total of 288 patients were planned to be enrolled, and all subjects were randomly assigned to group A (Anisodine Hydrobromide 1 mg bid) and group B (placebo 1 mg bid) according to a 1:1 ratio, with 144 subjects in each group.Both anisodine hydrobromide and placebo were produced and supplied by Chengdu First Pharmaceutical Limited Company. The enrolled subjects were orally administered Anisodine Hydrobromide 1 mg bid or placebo 1 mg bid for 12 consecutive weeks of treatment, and followed up for 4 weeks. That means doing face-to-face visits at the 4th, 8th, 12th and 16th weeks after dosing ,while affected by the epidemic or other special circumstances, video or telephone follow-up can be used. This study is divided into 3 phases: screening/baseline period (4 weeks, D-28\~D-1), double-blind treatment period (12 weeks, D1\~D84), follow-up period (4 weeks, D85-D112), a total of About 20 weeks. 4. In order to ensure the quality of the trial, the sponsor and the researcher shall discuss and formulate the clinical research plan before the trial officially begins. Good Clinical Practice(GCP) training was given to the relevant researchers who participated in the experiment. The research center must manage experimental drugs in accordance with (SOP), including receipt, storage, distribution and recycling. In accordance with the GCP guidelines, necessary steps should be taken during the design and implementation phase of the study to ensure that the data collected are accurate, consistent, complete and credible. All observed results and abnormal findings in clinical trials should be verified and recorded in time to ensure the reliability of the data. The instruments, equipment, reagents and standards used in various examination items in clinical trials should have strict quality standards and ensure that they work under normal conditions. The researcher inputs the information required by the program into the eCRF, and the inspector verifies whether the filling is complete and accurate, and instructs the staff of the research center to make necessary corrections and supplements. The drug regulatory department, the institutional review committee (IRB)/ independent ethics committee (IEC), sponsor inspectors and / or inspectors may conduct systematic inspections of clinical trial-related activities and documents to evaluate whether trials are conducted in accordance with the requirements of the study program, SOP and relevant regulations (e.g. GCP, GMP), and whether trial data are recorded in a timely, true, accurate and complete manner. The inspection should be carried out by personnel who are not directly involved in the clinical trial. 5. Statistical analysis plan: Efficacy evaluation: The primary endpoint was analyzed by Mixed Model for Repeated Measures(MMRM).And the primary endpoint analysis was based on the analysis results of Full Analysis Set(FAS) and Per Protocol Set(PPS).
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 288 participants |
Masking : | QUADRUPLE |
Masking Description : | In this double-blind clinical trial, Anisodine Hydrobromide was identical in appearance to the Anisodine Hydrobromide placebo.Patients, investigators (persons who screen patients, assess endpoints, and assess protocol compliance), and sponsor personnel associated with clinical research should be blinded. |
Primary Purpose : | PREVENTION |
Official Title : | 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 |
Actual Study Start Date : | 2023-10-30 |
Estimated Primary Completion Date : | 2025-10-30 |
Estimated Study Completion Date : | 2025-12-31 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
NOT YET RECRUITING
Jinjiang Municipal Hospital
Jinjiang, Fujian, China, 362200
NOT YET RECRUITING
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China, 362000
NOT YET RECRUITING
Guangdong 999 Brain Hospital
Guangzhou, Guangdong, China, 510510
NOT YET RECRUITING
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
NOT YET RECRUITING
Shenzhen University General Hospital
Shenzhen, Guangdong, China, 518055
NOT YET RECRUITING
The First People's Hospital of Zhaoqing
Zhaoqing, Guangdong, China, 526020
NOT YET RECRUITING
People's Hospital Affiliated to Jiangsu University/Zhenjiang First People's Hospital
Zhenjiang, Jiangsu, China, 212000
NOT YET RECRUITING
Dongyang People's Hospital
Dongyang, Zhejiang, China, 322100
NOT YET RECRUITING
Xinhua Hospital of Zhejiang Province
Hangzhou, Zhejiang, China, 310005
NOT YET RECRUITING
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China, 310012
RECRUITING
Kai Ming lU
Hangzhou, Zhejiang, China, 370001
NOT YET RECRUITING
The First People's Hospital of Huzhou City
huzhou, Zhejiang, China, 313000
NOT YET RECRUITING
The First People's Hospital of Jiande
J Ian's, Zhejiang, China, 311600
NOT YET RECRUITING
Jinhua People's Hospital
Jinhua, Zhejiang, China, 321000
NOT YET RECRUITING
Medical Community of Linhai First People's Hospital
Linhai, Zhejiang, China, 31700
NOT YET RECRUITING
Tiantai People's Hospital of Zhejiang Province
Tiantai, Zhejiang, China, 317200
NOT YET RECRUITING
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
NOT YET RECRUITING
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
May, Zhejiang, China, 322000
NOT YET RECRUITING
The Second People's Hospital of Yuhuan
Yuhuan, Zhejiang, China, 317600