Can a common antihistamine boost multiple sclerosis treatment?
NCT ID NCT07827716
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing whether adding terfenadine to standard first-line disease-modifying therapy is safe and may improve outcomes for adults with relapsing-remitting multiple sclerosis. About 100 participants aged 18 to 65 will be randomly assigned to receive either terfenadine plus standard therapy or standard therapy alone. Those in the terfenadine group take 60 mg by mouth once daily at bedtime for one month, with check-ups over 12 months to track safety and disease activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- terfenadine, an antihistamine, added to standard disease-modifying therapy
- What this could lead to
- If adding terfenadine helps, it could offer a low-cost, widely available pill to boost standard multiple sclerosis treatment.
- What could go wrong
- This is an early Phase 2 trial with 100 participants, so any benefit may not hold up in larger studies. Terfenadine can affect heart rhythm, and researchers will monitor for that.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2026
- Expected to finish
-
Oct 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Relapsing-remitting multiple sclerosis are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Under-the-Skin MS drug: can a shot replace an IV drip?
- Can Real-World data show how well multiple sclerosis patients stick with ofatumumab?
- Targeting hidden balance issues: a new therapy for early MS
- Can reading emotions explain social struggles in MS?
- Unlocking the Brain's role in relearning movement for MS patients
- Blood's tiny messengers may expose hidden brain injury