Terfenadine added to standard treatment for relapsing-remitting multiple sclerosis
Tests adding terfenadine to usual treatment in adults with relapsing-remitting multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07827716, who can take part
Where in China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chuan Qin
- Trial code
- NCT07827716
- Record updated
- 18 September 2026
- Original description
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.Read full original descriptionShow less
A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
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.
Inclusion: 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.
Exclusion: Use of drugs that may interact with terfenadine through CYP3A4 inhibition, including certain azole antifungal agents or macrolide antibiotics; Myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) class IV heart failure within 12 weeks before screening; Participation in another clinical trial within 3 months before screening; 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; 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; 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.