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A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis

2026年9月17日 更新者：Chuan Qin

The goal of this clinical trial is to evaluate the safety and tolerability of terfenadine when added to standard first-line disease-modifying therapy in adults with multiple sclerosis. The study will also explore whether adding terfenadine may help improve disease-related outcomes.

Researchers will compare participants who receive terfenadine plus standard first-line disease-modifying therapy with participants who receive standard first-line disease-modifying therapy alone.

Participants will:

Be randomly assigned to receive either terfenadine plus standard first-line disease-modifying therapy or standard first-line disease-modifying therapy alone.

Take terfenadine 60 mg once daily at bedtime for 1 month if assigned to the terfenadine group.

Attend study visits during screening, treatment, and follow-up over 12 months. Have physical examinations, vital sign checks, laboratory tests, electrocardiograms, imaging assessments, neurological evaluations, and collection of blood, stool, and cerebrospinal fluid samples at scheduled visits.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Multiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system that can cause neurological disability and disease progression. Current disease-modifying therapies can reduce relapses and MRI disease activity, but limitations remain in preventing disability progression and promoting remyelination or neuroprotection.

Terfenadine is a histamine H1 receptor antagonist. Preclinical evidence suggests that histamine signaling may be involved in immune and inflammatory processes relevant to MS. This study will evaluate the safety and tolerability of terfenadine as an adjunct to standard first-line disease-modifying therapy and explore its potential clinical effects in people with MS.

This is a single-center, open-label, randomized controlled clinical trial. Approximately 100 participants will be enrolled and randomly assigned in a 2:1 ratio to a terfenadine treatment group or a control group. Participants in the terfenadine group will receive terfenadine 60 mg orally once daily at bedtime for 1 month in addition to standard first-line disease-modifying therapy. Participants in the control group will receive standard first-line disease-modifying therapy alone.

Participants will be followed for 12 months. Study assessments will include physical examinations, vital signs, laboratory tests, electrocardiograms, imaging examinations, neurological and functional assessments, quality-of-life assessments, and collection of blood, stool, and cerebrospinal fluid samples at scheduled visits. Safety will be assessed throughout the study by recording and following adverse events and by reviewing relevant clinical and laboratory findings.

研究类型

介入性

注册 (估计的)

100

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Hubei
      • Wuhan、Hubei、中国、430030
        • 招聘中
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 首席研究员：
          • Daishi Tian
        • 首席研究员：
          • Chuan Qin
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Male or female participants aged 18 to 65 years, inclusive.
  2. Diagnosis of multiple sclerosis (MS) according to the 2024 revised McDonald diagnostic criteria.
  3. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  4. Participants must be able to understand the study requirements and provide written informed consent. If applicable, informed consent may be provided by the participant's legally authorized representative.

Exclusion Criteria:

  1. Use of drugs that may interact with terfenadine through CYP3A4 inhibition, including certain azole antifungal agents or macrolide antibiotics.
  2. Congenital long QT syndrome, atrioventricular block, abnormal baseline QTc interval (>450 ms in males or >470 ms in females), hypokalemia or hypomagnesemia, or concomitant use of drugs known to prolong the QT interval.
  3. Significant hepatic dysfunction.
  4. Active or clinically significant infection.
  5. Secondary demyelinating diseases of the central nervous system.
  6. Vascular, genetic, metabolic, neoplastic, toxic, or other diseases that may cause central nervous system demyelination or neurological symptoms that could interfere with study assessments.
  7. Myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) class IV heart failure within 12 weeks before screening.
  8. Pregnancy, breastfeeding, or plans to become pregnant during the study period.
  9. Inability or unwillingness to comply with the study follow-up schedule or study procedures.
  10. Contraindication to lumbar puncture.
  11. Inability or unwillingness to undergo the required magnetic resonance imaging (MRI) examinations.
  12. Participation in another clinical trial within 3 months before screening.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Terfenadine Plus Standard First-line Disease-Modifying Therapy
Participants will receive standard first-line disease-modifying therapy plus terfenadine 60 mg orally once daily at bedtime for 1 month, followed by observation through 12 months.
药品：Terfenadine
Terfenadine will be administered orally at a dose of 60 mg once daily at bedtime for 1 month as add-on therapy to standard first-line disease-modifying therapy.
药品：Standard First-line Disease-Modifying Therapy
Participants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice.
有源比较器：Standard First-line Disease-Modifying Therapy Alone
Participants will receive standard first-line disease-modifying therapy alone according to routine clinical practice and will be followed for 12 months.
药品：Standard First-line Disease-Modifying Therapy
Participants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Safety and tolerability of terfenadine during the treatment period
大体时间：Baseline through 1 month
Safety and tolerability will be assessed by the incidence and severity of adverse events and serious adverse events, as well as changes or clinically significant abnormalities in vital signs, physical examinations, clinical laboratory tests, electrocardiograms, and imaging examinations.
Baseline through 1 month

次要结果测量

结果测量
措施说明
大体时间
Safety and tolerability during the 12-month follow-up period
大体时间：Baseline through 12 months
Safety and tolerability will be assessed by the incidence and severity of adverse events and serious adverse events, as well as changes or clinically significant abnormalities in vital signs, physical examinations, clinical laboratory tests, electrocardiograms, and imaging examinations.
Baseline through 12 months
Change from baseline in cerebrospinal fluid white blood cell count
大体时间：Baseline, Month 1, and Month 12
Cerebrospinal fluid white blood cell count will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid albumin quotient
大体时间：Baseline, Month 1, and Month 12
Cerebrospinal fluid albumin quotient will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid neurofilament light chain (NfL)
大体时间：Baseline, Month 1, and Month 12
Cerebrospinal fluid neurofilament light chain (NfL) level will be measured at baseline, Month 1, and Month 12 in pg/mL, and the change from baseline will be evaluated.
Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid oligoclonal bands (OCB)
大体时间：Baseline, Month 1, and Month 12
Cerebrospinal fluid oligoclonal bands (OCB) will be assessed at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid kappa free light chain (kFLC)
大体时间：Baseline, Month 1, and Month 12
Cerebrospinal fluid kappa free light chain (kFLC) level will be measured at baseline, Month 1, and Month 12 in mg/L, and the change from baseline will be evaluated.
Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid IgG index
大体时间：Baseline, Month 1, and Month 12
Cerebrospinal fluid IgG index will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
Baseline, Month 1, and Month 12
Change from baseline in serum neurofilament light chain (NfL)
大体时间：Baseline, Month 1, Month 3, Month 6, and Month 12
Serum neurofilament light chain (NfL) levels will be measured at baseline and during follow-up. Changes in serum NfL from baseline will be evaluated at Month 1, Month 3, Month 6, and Month 12.
Baseline, Month 1, Month 3, Month 6, and Month 12
Change from baseline in Expanded Disability Status Scale (EDSS) score
大体时间：Baseline, Month 1, Month 6, and Month 12
Neurological disability will be assessed using the Expanded Disability Status Scale (EDSS), which ranges from 0 to 10, with higher scores indicating greater disability and a worse outcome. The change in EDSS score from baseline will be evaluated at Month 1, Month 6, and Month 12.
Baseline, Month 1, Month 6, and Month 12
Change from baseline in Timed 25-Foot Walk (T25FW) walking speed
大体时间：Baseline, Month 3, Month 6, and Month 12
Walking function will be assessed using the Timed 25-Foot Walk (T25FW). The change in T25FW walking speed from baseline will be evaluated at Month 3, Month 6, and Month 12.
Baseline, Month 3, Month 6, and Month 12
Change from baseline in Nine-Hole Peg Test (9HPT) completion time
大体时间：Baseline, Month 3, Month 6, and Month 12
Upper limb motor function will be assessed using the Nine-Hole Peg Test (9HPT). The change in the time required to complete the 9HPT from baseline will be evaluated at Month 3, Month 6, and Month 12.
Baseline, Month 3, Month 6, and Month 12
Change from baseline in Symbol Digit Modalities Test (SDMT) score
大体时间：Baseline, Month 6, and Month 12
Cognitive function will be assessed using the Symbol Digit Modalities Test (SDMT), which ranges from 0 to 110, with higher scores indicating better cognitive processing speed. The change in SDMT score from baseline will be evaluated at Month 6 and Month 12.
Baseline, Month 6, and Month 12
Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score
大体时间：Baseline, Month 6, and Month 12
Overall functional status will be assessed using the Multiple Sclerosis Functional Composite (MSFC), a standardized composite measure of neurological function based on the Timed 25-Foot Walk, 9-Hole Peg Test, and Paced Auditory Serial Addition Test. The MSFC score is expressed as a standardized z-score, with higher scores indicating better functional performance. The change in MSFC score from baseline will be evaluated at Month 6 and Month 12.
Baseline, Month 6, and Month 12
Change from baseline in EQ-5D-5L score
大体时间：Baseline, Month 1, and Month 12
Health-related quality of life will be assessed using the 5-Level EuroQol 5-Dimension questionnaire (EQ-5D-5L). The descriptive system consists of five dimensions, each rated from 1 to 5, with higher dimension scores indicating more severe problems. The EQ-5D-5L responses may be converted to an index value using the applicable value set, with higher index values indicating better health-related quality of life. The change in EQ-5D-5L score from baseline will be evaluated at Month 1 and Month 12.
Baseline, Month 1, and Month 12
Confirmed disability progression (CDP) rate at Month 6
大体时间：Baseline to Month 6
Confirmed disability progression will be evaluated at Month 6. CDP will be defined as an increase in EDSS score of at least 1.0 point for participants with a baseline EDSS score of 5.5 or lower, or at least 0.5 point for participants with a baseline EDSS score greater than 5.5, or an increase of at least 20% in T25FW completion time or 9HPT completion time.
Baseline to Month 6
Annualized relapse rate at Month 12
大体时间：Baseline through Month 12
Disease relapse will be assessed throughout the study, and the annualized relapse rate will be evaluated through Month 12. The annualized relapse rate at Month 12 will be compared between the terfenadine treatment group and the active comparator group.
Baseline through Month 12
MRI T2 lesion activity at Month 12
大体时间：Baseline and Month 12
Brain and spinal cord MRI findings will be evaluated at Month 12. The assessment will include the number of new or enlarging T2 hyperintense lesions, changes from baseline in cumulative T2 lesion number and lesion volume, and the proportion of participants without new T2 hyperintense lesions.
Baseline and Month 12
Gadolinium-enhancing T1 lesions on brain MRI at Month 12
大体时间：Baseline and Month 12
Brain MRI findings will be evaluated at Month 12. The assessment will include the change from baseline in the number of gadolinium-enhancing T1 lesions and the proportion of participants without gadolinium-enhancing lesions.
Baseline and Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chuan Qin

调查人员

  • 首席研究员：Chuan Qin、Tongji Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月15日

初级完成 (估计的)

2027年10月30日

研究完成 (估计的)

2028年10月30日

研究注册日期

首次提交

2026年9月6日

首先提交符合 QC 标准的

2026年9月17日

首次发布 (实际的)

2026年9月18日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TJ-IRB202607023

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared with other researchers because the study data are intended for analysis by the research team and publication of the study results only.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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