NCT07385755进行中（未招募）不适用
Efficacy of Desvenlafaxine in the Preventive Treatment of Frequent Migraines -- Multicenter, Prospective, Randomized, Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- the change from baseline in monthly migraine days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
研究概览
简要总结
To evaluate whether Desvenlafaxine can reduce the frequency and severity of migraine attacks in patients.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants must be males or females aged 18 years or older
- •Headache meets the diagnostic criteria for episodic migraine according to ICHD-3; with at least a one-year history of migraines and onset before age
- •During the three months prior to the screening visit (one month defined as four weeks), participants must have experienced≥4 and <15 episodes of moderate to severe headaches per month, and had at least ≥6 migraine days within a 4-week run-in period.
- •Obtain the patient's informed consent.
排除标准
- •Have a history of allergy to Desvenlafaxine, or have used Desvenlafaxine within 4 weeks prior to the start of the treatment period
- •Are currently taking or require concomitant administration of contraindicated medications as stated in the package insert, such as monoamine oxidase inhibitors (MAOIs).
- •Comorbid with other types of headaches, such as trigeminal autonomic cephalalgias, more than one episode of tension-type headache per month, or secondary headaches (e.g., those caused by intracranial infections, craniocerebral trauma, cerebrovascular diseases)
- •Severe psychiatric disorders, such as schizophrenia; poorly controlled epilepsy, cognitive impairments, and other chronic pain conditions; serious concomitant medical illnesses that pose significant health risks, including uncontrolled hypertension, cardiac disease, hepatic dysfunction, renal insufficiency, infections; any medical condition or prior surgery likely to affect the absorption, metabolism, or excretion of the study medication
- •Use of venlafaxine analogues, such as serotonin-norepinephrine reuptake inhibitors (SNRIs); unstable use of other types of preventive medications for migraine, including calcitonin gene-related peptide (CGRP) antagonists, topiramate, etc. (≥3 months)
- •Meet the diagnostic criteria for chronic migraine and medication overuse (MO); alcohol dependence or substance use
- •Inability to comprehend the study protocol due to factors including but not limited to low educational attainment, impaired verbal/language function, visual or auditory deficits; failure to accurately complete research documentation (e.g., headache diaries) or incapacity to engage with assessment instruments
- •Female subjects who are trying to conceive, pregnant or breastfeeding, and those not using contraception
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: Placebo (Drug)
Desvenlafaxine
Experimental
干预措施: Desvenlafaxine (Drug)
结局指标
主要结局
the change from baseline in monthly migraine days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
时间窗: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
the change from baseline in monthly migraine days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
次要结局
- Days with migraine every 4 weeks during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)(during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12))
- Moderate/severe headache days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)(during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12))
- The rate of effective responders during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)(during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12))
- Headache severity during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)(during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12))
- Cumulative headache duration during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)(during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12))
- Change in Anxiety and Depression Scores(during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12))
- Changes in daily life behavioral capabilities(During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12))
研究者
研究点 (1)
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