A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine
A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Terfenadine
Histamine H1 receptor antagonist
Given to everyone in the trial
- Standard First-line Disease-Modifying Therapy
What it measured
Main measures
Safety and tolerability of terfenadine during the treatment period
Baseline through 1 month
Safety
Other measures (18)
Safety and tolerability during the 12-month follow-up period
Baseline through 12 months
SafetyChange from baseline in cerebrospinal fluid white blood cell count
Baseline, Month 1, and Month 12
Blood or spinal fluid markersChange from baseline in cerebrospinal fluid albumin quotient
Baseline, Month 1, and Month 12
Blood or spinal fluid markersChange from baseline in cerebrospinal fluid neurofilament light chain (NfL)
Baseline, Month 1, and Month 12
Blood or spinal fluid markersChange from baseline in cerebrospinal fluid oligoclonal bands (OCB)
Baseline, Month 1, and Month 12
Blood or spinal fluid markersChange from baseline in cerebrospinal fluid kappa free light chain (kFLC)
Baseline, Month 1, and Month 12
Blood or spinal fluid markersChange from baseline in cerebrospinal fluid IgG index
Baseline, Month 1, and Month 12
Blood or spinal fluid markersChange from baseline in serum neurofilament light chain (NfL)
Baseline, Month 1, Month 3, Month 6, and Month 12
Blood or spinal fluid markersChange from baseline in Expanded Disability Status Scale (EDSS) score
Baseline, Month 1, Month 6, and Month 12
Disability progressionChange from baseline in Timed 25-Foot Walk (T25FW) walking speed
Baseline, Month 3, Month 6, and Month 12
Disability progressionWalking and mobility
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Aug 2026
Main results due
Oct 2027
Finished
Oct 2028