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

NCT07827716 | Recruiting Phase 2

• 1 other identifier: TJ-IRB202607023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Terfenadine; Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Disease-Modifying Therapy

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of terfenadine during the treatment period

  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

Secondary Outcomes (18)

• 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

Study Arms (2)

Terfenadine Plus Standard First-line Disease-Modifying Therapy

EXPERIMENTAL

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.

Drug: Terfenadine; Drug: Standard First-line Disease-Modifying Therapy

Standard First-line Disease-Modifying Therapy Alone

ACTIVE COMPARATOR

Participants will receive standard first-line disease-modifying therapy alone according to routine clinical practice and will be followed for 12 months.

Drug: Standard First-line Disease-Modifying Therapy

Interventions

Terfenadine DRUG

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.

Terfenadine Plus Standard First-line Disease-Modifying Therapy

Standard First-line Disease-Modifying Therapy DRUG

Participants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice.

Standard First-line Disease-Modifying Therapy Alone; Terfenadine Plus Standard First-line Disease-Modifying Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chuan Qin: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Terfenadine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chuan Qin

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian Chen

CONTACT

+8617371539505; chenlian318@163.com

Shu Fan

CONTACT

+8618732327876; shufan_fs@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A single-center, open-label, randomized, parallel-group controlled clinical trial. Participants will be randomly assigned in a 2:1 ratio to receive either terfenadine plus standard first-line disease-modifying therapy or standard first-line disease-modifying therapy alone.

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 18, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)