RecruitingPhase 2NCT07827716

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


Sponsor

Chuan Qin

Enrollment

100 participants

Start Date

Aug 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Standard First-line Disease-Modifying Therapy and a drug called Terfenadine for people with relapsing remitting multiple sclerosis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTerfenadine

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.

DRUGStandard First-line Disease-Modifying Therapy

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


Locations(1)

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

Wuhan, Hubei, China

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NCT07827716


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