NCT07827716RecruitingPhase 2
A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 15 Aug 2026
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Chuan Qin
- Diseases
- Multiple sclerosis
- NCT number
- NCT07827716
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 15 Aug 2026 to the primary completion date, 30 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.