NCT05411978Unknown4 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Parallel Pilot Study to Evaluate Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2022年5月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Changes in the migraine days per 4 weeks relative to the baseline.
研究概览
简要总结
This is a multi-center, prospective, double-blind randomized controlled trial on a sample of patients with migraine. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •Male or female participants ages 18 to 65 years;
- •At least a 1-year history of migraine with or without aura is consistent with a diagnosis according to the ICHD-3;
- •Migraine onset before age 50 years;
- •History of 4 to 15 migraine attacks days per month in each of the 3 months prior to the screening visit;
- •The number of headache attacks <15 days/month during the 3 months prior to the screening visit;
- •Be willing to use effective contraception during the trial and for 28 days after the end of the last dose;
- •Sign the informed consent form.
- •History of 4 to 14 migraine attacks days within 4 weeks during the screening visit.
- •The number of headache attacks <14 days/month within 4 weeks during the screening visit;
- •Completed at least 23 days of the electronic diary within 28 days during the screening visit. And the participant is to be able to read, understand and complete the study questionnaire and headache diary;
- •Understand and comply with the study procedures and methods, and voluntarily participate in this study.
排除标准
- •Participants diagnosed with probable migraine by ICHD-3
- •Current or previous diagnosis of primary, secondary, or painful cranial neuropathy other than migraine (diagnostic criteria according to ICHD-3)
- •Prior ineffectiveness after adequate treatment with more than 2 medications, which are listed below: Divalproex, sodium valproate; topiramate; beta-blockers; Tricyclic antidepressants; serotonin-norepinephrine reuptake inhibitors; Flunarizine, Verapamil; Lisinopril, Candesartan.
- •Definition of failure to treat: frequency, duration, and severity of headache 6 weeks after administration of the degree of the above drug does not decrease.
- •Use of other devices or prohibited medications such as painkillers containing opioids for the treatment of migraine within 2 months before or during the screening visit
- •Therapeutic injections of Botulinum toxin in the head, face, or neck within 4 months before screening and during the study periods
- •Simultaneous use of 2 or more drugs within 2 months before or during the screening visit may be prophylactic Medications for migraine effects (if used only 1 prophylactic drug, the dose must be stable for 2 months before the screening visit and throughout the study period)
- •The following situations occur within 2 months before the screening period begins: take ergotamines or triptans at least 10 days per month, or take non-steroidal anti-inflammatory drugs (NSAID) only every month ≥15 days, NSAID combination ≥10 days, or use opioid or barbiturate analgesics ≥4 days per month;
- •Participants use the prohibited drugs such as painkillers containing opioids, devices, or regimens during treatment.
- •History of active chronic pain syndrome (e.g., fibromyalgia, chronic pelvic pain, face Pain, etc.);
- •History of mental illness (e.g., schizophrenia or bipolar disorder) or Patient Health Questionnaire (PHQ-9) score ≥
- •If the participant has a history of anxiety or depression (PHQ-9 score < 15) and takes no more than one psychotropic drug, the participant will be allowed to enter. (participant must take a steady dose of treatment within 3 months before the screening visit)
- •Severe neurological disorders other than migraines (including febrile seizures);
- •History of a malignant tumor within 5 years before the screening visit, except for non-melanoma skin cancer, cervical or ductal carcinoma in situ;
- •The screening visit meets any of the following laboratory test values: Alanine transaminase (ALT) or aspartate aminotransferase(AST) >1.5×ULN, or total bilirubin >1.5×ULN (except for participants diagnosed with Gilbert syndrome);
- •History of myocardial infarction, stroke, or transient ischemic attack, unstable angina or coronary bypass surgery within 12 months before the screening visit
- •Expose participants to significant risk or confuse the study
- •Based on clinical interviews or C-SSRS, the investigator believes that the subject has self-harmed or harmed him Human risk;
- •History of drugs or alcohol abuse within 12 months before the screening visit
- •Pregnant, planning pregnancy, or Lactating women;
- •Fertile female participants are unwilling to use an effective contraceptive during the study period Method.
- •Infertile women as follows: history of menopause, age ≥ 55 years, menopause ≥12 months.
- •Age < 55 years, free from spontaneous menstruation for at least 2 years. Age < 55, has spontaneous menstruation in the past 1 year, but currently amenorrhea (e.g., Spontaneous or secondary to hysterectomy), and postmenopausal gonadotropin levels gonadotropin Luteinizing hormone (LH), follicle-stimulating Hormone> 40 IU/L or postmenopausal estradiol level <5 ng/dL History of bilateral oophorectomy, hysterectomy, or bilateral salpingectomy
- •Participated in other clinical trials within the first 3 months
- •Known allergy to Idebenone or any of its ingredients(e.g., lactose intolerant)；
- •The participants are employees or immediate family members of the research center (parents, spouses, siblings, or children).
研究组 & 干预措施
Idebenone 30 mg+ Placebo 60 mg
Placebo Comparator
Idebenone 30 mg+ placebo 60 mg TID Oral ,for 12 weeks
干预措施: Idebenone+ placebo (Drug)
Idebenone 90 mg
Experimental
Idebenone 90 mg TID Oral ,for 12 weeks
干预措施: Idebenone (Drug)
Placebo 90 mg
Placebo Comparator
Placebo 90 mg TID Oral,for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the migraine days per 4 weeks relative to the baseline.
时间窗: baseline, 4,8,12 weeks
Days with migraine in the last four weeks from a daily headache diary.
次要结局
- Frequency of headache attacks per 4 weeks as compared to baseline.(baseline,at 4,8,12 weeks)
- Change in dose of acute drug use per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Percentage of participants with at Least 50%, 75% and 100% reduction in the Number of Days of Migraine Attacks per 4 weeks.(baseline,at 4,8,12 weeks)
- Change in peak headache pain intensity per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in the number of without headache days per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in The Headache Impact Test(HIT-6) score per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in The Functional Impairment Scale (FIS) score per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Changes in the moderate / severe headache days per 4 weeks relative to the baseline(baseline,at 4,8,12 weeks)
- Change in frequency of acute drug use per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in The Patient Health Questionnaire-9 (PHQ-9) score per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in average headache intensity per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in cumulative hours of moderate/severe headache pain per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in the number of without symptoms days per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in The Migraine-Specific Quality-of-Life Questionnaire, Version 2.1 (MSQ Version 2.1) score per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Patient Global Impression of Change (PGIC).(baseline,at 4,8,12 weeks)
- Change in The General Anxiety Disorder-7(GAD-7) score per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in The European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) scores per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in The Fatigue Severity Scale (FSS) score per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in The Modified Migraine Disability Assessment Scale score per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
- Change in The Columbia-Suicide Severity Rating Scale (C-SSRS) score per 4 weeks relative to baseline.(baseline,at 4,8,12 weeks)
研究者
Yonggang.wang
Director
Beijing Tiantan Hospital
研究点 (1)
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