Recruiting
Phase 2
A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
Condition(s) studied
Relapsing Remitting Multiple Sclerosis
Investigational drug(s) / intervention(s)
TerfenadineStandard First-line Disease-Modifying Therapy
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.
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.
Study 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
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.
Primary outcome measure(s)
- Safety and tolerability of terfenadine during the treatment period — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology |
Wuhan |
Hubei |
Recruiting |