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

RecruitingPhase 2Ages 18 Years - 65 YearsAllChuan Qin
NCT07827716 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Terfenadine
  • Standard First-line Disease-Modifying Therapy
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Where

1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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