NCT05416476招募中3 期
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
Second Affiliated Hospital, School of Medicine, Zhejiang University19 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2023年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 288
- 试验地点
- 19
- 主要终点
- The Change of Migraine Days
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subjects with any of the following cannot participate in this study:
- •Subject diagnosed with possible migraine according to ICHD-3(2018);
- •Current and previous diagnosis of primary headache, secondary headache, or painful cranial neuropathy other than migraine(diagnostic criteria are defined according to ICHD-3,2018);
- •Past use of more than two of the following 7 drugs is ineffective after adequate use, the types of these drugs are as follows:
- •Type 1: Divalproex, Sodium Valproate
- •Type 2: Topiramate
- •Type 3: Beta blockers(such as: Atenolol, Bisoprolol, Metoprolol, Nadolol, Nebivolol, Pindolol, Propranolol, Timolol)
- •Type 4: Tricyclic antidepressants(TCA) (such as: Amitriptyline, Nortriptyline, Protriptyline)
- •Type 5: Serotonin-norepinephrine reuptake inhibitors (SNRIs) (such as: Venlafaxine, Desvenlafaxine, Duloxetine, Milnacipran)
- •Type 6: Flunarizine, Verapamil
- •Type 7: lisinopril, Candesartan
- •Definition of treatment failure: No reduction in headache frequency, duration, or severity after 6 weeks of administration of the above drugs.
- •The following conditions are not defined as treatment failure:
- •Lack of sustained response to medication;
- •Can not be tolerated dose of drug
- •Use of drugs known to have significant interactions with the study drug (anisodine hydrobromide) (eg donepezil, donepezil hydrochloride, rivastigmine, etc.) in the 2 months prior to the baseline period and throughout the study period；
- •Use of prohibited drugs, Chinese patent drug, Chinese herbal medicines, instruments or therapies, etc. 2 months before the baseline period or during the baseline period (more details are in Prohibited Drugs/Treatments);
- •Subjects who intend to undergo head, face or neck injections of therapeutic or cosmetic Botulinum Toxin(such as Dysport, Botox, Xeomin, Myobloc and JeuvwauTM) during the study period or within 4 months before screening;
- •Simultaneous use of two or more drugs that may have migraine preventive effects within 2 months before the start of the baseline period or during the baseline period (more details are in Annex- The List of Migraine Preventive Medications ) (If only one prophylactic drug is used, the dose must be stable for the two months prior to the baseline period and throughout the study);
- •The following occurred within two months prior to the start of the baseline period:
- •Taking Ergotamines or Triptans for ≥10 days per month, or
- •Taking NSAIDs alone for ≥15 days compound or preparation of NSAIDs≥10 days, or
- •Taking Opioid or Barbiturate analgesics for ≥4 days per month
- •Subjects are expected to use the following prohibited drugs, Chinese patent drug, Chinese herbal medicines, instruments or protocols during double-blind treatment (more details are in Prohibited Drugs/Treatments);
- •Subject has active chronic pain syndrome (eg, fibromyalgia, chronic pelvic pain, facial pain, etc.);
- •Subject has a history of mental illness (eg, schizophrenia or bipolar disorder) or PHQ-9 score≥15；Subjects are allowed to enter the double-blind treatment period if they had a history of anxiety or depression and were taking no more than one psychotropic drug (excluding contraindicated drugs) (Subjects must have taken a stable therapeutic dose within 3 months prior to the baseline period);
- •Have a serious neurological disorder other than migraines (Note: Do not rule out single children febrile convulsion);
- •Patients with a history of malignant tumour within five years prior to the screening period, excluding non-melanoma skin cancer, cervical or breast ductal carcinoma in situ;
- •The screening period meets any of the following laboratory values:
- •Alanine transaminase (ALT) or aspartate aminotransferase (AST) >1.5×（upper limit of normal, ULN）, or
- •Total bilirubin(TBIL) >1.5×ULN （Subjects with diagnosed Gilbert syndrome excluded）
- •Heart disease such as coronary heart disease, severe heart failure and arrhythmia; history of glaucoma, bleeding disorders, stroke, transient ischemic attack (TIA), reconstructive surgery;
- •The subject has factors that the investigator believes may put the subject at significant risk or may confound the results of the study; The subject has any medical or other reasons for being unfit to participate in the study;
- •According to clinical interviews or C-SSRS questionnaires, the researcher believes that the subject is at risk of self-harm or harm to others;
- •Within 12 months before the screening period, according to the subject's medical records or the subject's self-reported history of drug or alcohol abuse;
- •Subjects expected to be pregnant or breastfeeding during the study period, or had a positive urine pregnancy test result at screening;
- •During the study period, female subjects of childbearing potential were reluctant to use an acceptable method of effective contraception; Infertile women are defined as follows:
- •Have a history of menopause, defined as: Age: ≥55 years old, Menopause ≥12 months, or Age:<55 years old, no spontaneous menstruation for at least 2 years，or Age:<55 years old, have spontaneous menstruation in the past 1 year, but current is amenorrhea (spontaneous or secondary to hysterectomy), and abnormal postmenopausal Gonadotropin levels: luteinizing hormone(LH), follicle-stimulating hormone(FSH)>40IU/L or postmenopausal estradiol level <5ng/dL, or
- •Have a history of bilateral oophorectomy, or
- •Have a history of hysterectomy, or
- •Have a history of bilateral salpingectomy
- •Subjects who participated in other clinical trials within 3 months before the screening period;
- •Subjects who are allergic to anisodine hydrobromide or anisodine hydrobromide excipients;
- •Subjects who cannot maintain their original diet and living habits during the trial;
- •Subjects who intend to take estrogen and/or progesterone drugs during the screening period or after enrollment;
- •Subject is a researcher involved in the study or an immediate family member (parent, spouse, sibling or child).
研究组 & 干预措施
Anisodine Hydrobromide
Experimental
Participants in this group took oral Anisodine Hydrobromide tablets 1 mg bid for 12 consecutive weeks and were followed up for 12 weeks.
干预措施: Anisodine Hydrobromide (Drug)
Anisodine Hydrobromide Placebo
Placebo Comparator
Participants in this group took oral Anisodine Hydrobromide placebo tablets 1 mg bid for 12 consecutive weeks and were followed up for 12 weeks.
干预措施: Anisodine Hydrobromide placebo (Drug)
结局指标
主要结局
The Change of Migraine Days
时间窗: 12-week treatment period（Day 1-Day 84）
The change of migraine days per 4 weeks during the 12-week treatment period compared with baseline. Baseline refers to the frequency of migraine attacks within the 28 days prior to randomization (baseline period, i.e., D-28 to D-1). Headache data were captured through an electronic diary.
次要结局
- The Responder Rate of at Least 50%, 75% and 100% Reduction of Migraine Days(12-week treatment period（Day 1-Day 84）)
- The Dose of Acute Medication Use(12-week treatment period（Day 1-Day 84）)
- The Change of Frequency of Medications Use(12-week treatment period（Day 1-Day 84）)
- The Change of Headache-free Days(12-week treatment period（Day 1-Day 84）)
- The Change of Migraine Disability Assessment questionnaire (mMIDAS) Score(12-week treatment period（Day 1-Day 84）)
- The Change of Headache Attack Frequency(12-week treatment period（Day 1-Day 84）)
- The Change of Moderate / Severe Headache Days(12-week treatment period（Day 1-Day 84）)
- The Change of Peak Headache Pain Intensity(12-week treatment period（Day 1-Day 84）)
- The Change of Average Headache Intensity(12-week treatment period（Day 1-Day 84）)
- The Change of Cumulative Hours of Moderate / Severe Headache(12-week treatment period（Day 1-Day 84）)
- The Change of Days without Symptoms(12-week treatment period（Day 1-Day 84）)
- The Change of Headache Impact Test (HIT-6) Score(12-week treatment period（Day 1-Day 84）)
- The Change of Generalized Anxiety Disorder (GAD-7) Score(12-week treatment period（Day 1-Day 84）)
- The Change of Migraine Specific Quality of Life questionnaire(MSQ v2.1) Score(12-week treatment period（Day 1-Day 84）)
- The Change of The Patient Global Impression of Change (PGIC) Score(12-week treatment period（Day 1-Day 84）)
- The Change of Patient Health Questionnaire-9(PHQ-9) Score(12-week treatment period（Day 1-Day 84）)
- The Change of Functional Impairment Scale (FIS) Score(12-week treatment period（Day 1-Day 84）)
- The Change of EuroQol-5 Dimension questionnaire (EQ-5D) Score(12-week treatment period（Day 1-Day 84）)
- The Change of Columbia-Suicide Severity Rating Scale (C-SSRS) Score(12-week treatment period（Day 1-Day 84）)
研究者
研究点 (19)
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