A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChuan Qin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Use of drugs that may interact with terfenadine through CYP3A4 inhibition, including certain azole antifungal agents or macrolide antibiotics.
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.
Active or clinically significant infection.
Trial design
Design model
Parallel
Treatments tested in this trial
Terfenadine
DrugTerfenadine will be administered orally at a dose of 60 mg once daily at bedtime for 1 month as add-on therapy to standard first-line disease-modifying therapy.
Standard First-line Disease-Modifying Therapy
DrugParticipants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Terfenadine Plus Standard First-line Disease-Modifying TherapyExperimental treatment 2 interventions
Group B: Standard First-line Disease-Modifying Therapy AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of terfenadine during the treatment period
Safety and tolerability will be assessed by the incidence and severity of adverse events and serious adverse events, as well as changes or clinically significant abnormalities in vital signs, physical examinations, clinical laboratory tests, electrocardiograms, and imaging examinations.
Time frame
Baseline through 1 monthSecondary outcomes
1
Safety and tolerability during the 12-month follow-up period
Safety and tolerability will be assessed by the incidence and severity of adverse events and serious adverse events, as well as changes or clinically significant abnormalities in vital signs, physical examinations, clinical laboratory tests, electrocardiograms, and imaging examinations.
Time frame
Baseline through 12 months2
Change from baseline in cerebrospinal fluid white blood cell count
Cerebrospinal fluid white blood cell count will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
Time frame
Baseline, Month 1, and Month 123
Change from baseline in cerebrospinal fluid albumin quotient
Cerebrospinal fluid albumin quotient will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
Time frame
Baseline, Month 1, and Month 124
Change from baseline in cerebrospinal fluid neurofilament light chain (NfL)
Cerebrospinal fluid neurofilament light chain (NfL) level will be measured at baseline, Month 1, and Month 12 in pg/mL, and the change from baseline will be evaluated.
Time frame
Baseline, Month 1, and Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chuan Qin
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov