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

17 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Lian Chen
  • Número de teléfono: +8617371539505
  • Correo electrónico: chenlian318@163.com

Copia de seguridad de contactos de estudio

  • Nombre: Shu Fan
  • Número de teléfono: +8618732327876
  • Correo electrónico: shufan_fs@163.com

Ubicaciones de estudio

  • Porcelana
    • Hubei
      • Wuhan, Hubei, Porcelana, 430030
        • Reclutamiento
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Investigador principal:
          • Daishi Tian
        • Investigador principal:
          • Chuan Qin
        • Contacto:
        • Contacto:
          • Shu Fan
          • Número de teléfono: +8618732327876
          • Correo electrónico: shufan_fs@163.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: 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.
Droga: 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.
Comparador activo: 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.
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety and tolerability of terfenadine during the treatment period
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety and tolerability during the 12-month follow-up period
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Chuan Qin

Investigadores

  • Investigador principal: Chuan Qin, Tongji Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de agosto de 2026

Finalización primaria (Estimado)

30 de octubre de 2027

Finalización del estudio (Estimado)

30 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

6 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Publicado por primera vez (Actual)

18 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TJ-IRB202607023

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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