Terfenadine added to standard MS therapy in relapsing MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label randomized trial in adults with relapsing-remitting MS. Participants are assigned in a 2:1 ratio to receive terfenadine 60 mg nightly for one month in addition to their standard first-line disease-modifying therapy, or standard therapy alone, and are followed for 12 months. The study assesses safety and tolerability, with monitoring including physical exams, vital signs, labs, ECGs, imaging, neurological assessments, quality of life, and sample collection. The trial explores whether terfenadine can provide additional clinical benefit when combined with standard therapy, building on preclinical data suggesting histamine signaling may influence immune and inflammatory processes in MS. Enrollment is about 100 participants, conducted at Tongji Hospital in Wuhan, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Chuan Qin — Tongji Hospital
• Study coordinator: Lian Chen
• Email: chenlian318@163.com
• Phone: +8617371539505

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• People with Relapsing-Remitting MS try subcutaneous ocrelizumab at their clinic

  This study looks at how satisfied people with relapsing-remitting MS feel about receiving subcutaneous ocrelizumab in routine care.

  Recruiting at 2 sites Hoffmann-La Roche · Pardubice, Pardubice Region and 1 other locations · NCT07827586

• HiHat: Rituximab Followed by Cladribine in Relapsing-Remitting MS

  This trial tests whether giving rituximab and then cladribine in sequence is safe and doable for people with relapsing-remitting MS.

  Recruiting at 3 sites Phase 2 Uppsala University · Falun and 3 other locations · NCT07517185

• SetPoint implant to promote remyelination in relapsing-remitting MS

  This study will try a small implanted vagus-nerve stimulator alongside standard MS treatments to promote remyelination in adults with relapsing-remitting MS.

  Recruiting at 9 sites SetPoint Medical Corporation · Irvine, California and 8 other locations · NCT06796504

• Examining personalized treatment for multiple sclerosis with rituximab and ocrelizumab

  This study is testing whether measuring the levels of two different medications, rituximab and ocrelizumab, can help doctors personalize treatment for people with relapsing-remitting multiple sclerosis who are just starting therapy.

  Recruiting Haukeland University Hospital · Bergen, Vestland · NCT06663111

• Understanding how B-cell therapies affect immune responses in multiple sclerosis

  This study is looking at how B-cell therapies for relapsing-remitting multiple sclerosis affect the immune system and how these changes relate to patients' health over two years.

  Recruiting Heinrich-Heine University, Duesseldorf · Düsseldorf · NCT06586177

• Comparing CT-P53 and Ocrevus for treating relapsing-remitting multiple sclerosis

  This study is testing if a new treatment called CT-P53 works as well and is as safe as Ocrevus for people with relapsing-remitting multiple sclerosis.

  Recruiting Phase 3 Celltrion · Poznan · NCT05906992

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.