A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety and tolerability of terfenadine during the treatment period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female participants aged 18 to 65 years, inclusive.
- •Diagnosis of multiple sclerosis (MS) according to the 2024 revised McDonald diagnostic criteria.
- •Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
- •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.
排除标准
- •Use of drugs that may interact with terfenadine through CYP3A4 inhibition, including certain azole antifungal agents or macrolide antibiotics.
- •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.
- •Significant hepatic dysfunction.
- •Active or clinically significant infection.
- •Secondary demyelinating diseases of the central nervous system.
- •Vascular, genetic, metabolic, neoplastic, toxic, or other diseases that may cause central nervous system demyelination or neurological symptoms that could interfere with study assessments.
- •Myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) class IV heart failure within 12 weeks before screening.
- •Pregnancy, breastfeeding, or plans to become pregnant during the study period.
- •Inability or unwillingness to comply with the study follow-up schedule or study procedures.
- •Contraindication to lumbar puncture.
- •Inability or unwillingness to undergo the required magnetic resonance imaging (MRI) examinations.
- •Participation in another clinical trial within 3 months before screening.
研究组 & 干预措施
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.
干预措施: Standard First-line Disease-Modifying Therapy (Drug)
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.
干预措施: Standard First-line Disease-Modifying Therapy (Drug)
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.
干预措施: Terfenadine (Drug)
结局指标
主要结局
Safety and tolerability of terfenadine during the treatment period
时间窗: 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.
次要结局
- Safety and tolerability during the 12-month follow-up period(Baseline through 12 months)
- Change from baseline in cerebrospinal fluid white blood cell count(Baseline, Month 1, and Month 12)
- Change from baseline in cerebrospinal fluid albumin quotient(Baseline, Month 1, and Month 12)
- Change from baseline in cerebrospinal fluid neurofilament light chain (NfL)(Baseline, Month 1, and Month 12)
- Change from baseline in cerebrospinal fluid oligoclonal bands (OCB)(Baseline, Month 1, and Month 12)
- Change from baseline in cerebrospinal fluid kappa free light chain (kFLC)(Baseline, Month 1, and Month 12)
- Change from baseline in cerebrospinal fluid IgG index(Baseline, Month 1, and Month 12)
- Change from baseline in serum neurofilament light chain (NfL)(Baseline, Month 1, Month 3, Month 6, and Month 12)
- Change from baseline in Expanded Disability Status Scale (EDSS) score(Baseline, Month 1, Month 6, and Month 12)
- Change from baseline in Timed 25-Foot Walk (T25FW) walking speed(Baseline, Month 3, Month 6, and Month 12)
- Change from baseline in Nine-Hole Peg Test (9HPT) completion time(Baseline, Month 3, Month 6, and Month 12)
- Change from baseline in Symbol Digit Modalities Test (SDMT) score(Baseline, Month 6, and Month 12)
- Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score(Baseline, Month 6, and Month 12)
- Change from baseline in EQ-5D-5L score(Baseline, Month 1, and Month 12)
- Confirmed disability progression (CDP) rate at Month 6(Baseline to Month 6)
- Annualized relapse rate at Month 12(Baseline through Month 12)
- MRI T2 lesion activity at Month 12(Baseline and Month 12)
- Gadolinium-enhancing T1 lesions on brain MRI at Month 12(Baseline and Month 12)
研究者
Chuan Qin
Professor
Tongji Hospital