Relapsing Remitting Multiple SclerosisPhase 2NCT07827716
A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing Terfenadine and Standard First-line Disease-Modifying Therapy in people with Relapsing Remitting Multiple Sclerosis, run by Chuan Qin at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Terfenadine and Standard First-line Disease-Modifying Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 30 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Show all 12Show fewer
- Myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) class IV heart failure within 12 weeks before screening.
- 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.
- Participation in another clinical trial within 3 months before screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Lian Chen, +8617371539505, chenlian318@163.com
Shu Fan, +8618732327876, shufan_fs@163.com
About this study
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.
Read more
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.
Read the detailed description
Multiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system that can cause neurological disability and disease progression. Current disease-modifying therapies can reduce relapses and MRI disease activity, but limitations remain in preventing disability progression and promoting remyelination or neuroprotection.
Terfenadine is a histamine H1 receptor antagonist. Preclinical evidence suggests that histamine signaling may be involved in immune and inflammatory processes relevant to MS. This study will evaluate the safety and tolerability of terfenadine as an adjunct to standard first-line disease-modifying therapy and explore its potential clinical effects in people with MS.
This is a single-center, open-label, randomized controlled clinical trial. Approximately 100 participants will be enrolled and randomly assigned in a 2:1 ratio to a terfenadine treatment group or a control group. Participants in the terfenadine group will receive terfenadine 60 mg orally once daily at bedtime for 1 month in addition to standard first-line disease-modifying therapy. Participants in the control group will receive standard first-line disease-modifying therapy alone.
Participants will be followed for 12 months. Study assessments will include physical examinations, vital signs, laboratory tests, electrocardiograms, imaging examinations, neurological and functional assessments, quality-of-life assessments, and collection of blood, stool, and cerebrospinal fluid samples at scheduled visits. Safety will be assessed throughout the study by recording and following adverse events and by reviewing relevant clinical and laboratory findings.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Terfenadine, Standard First-line Disease-Modifying Therapy
- Keywords
- Terfenadine, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Disease-Modifying Therapy
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerfenadineDrug
Terfenadine 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 TherapyDrug
Participants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Terfenadine Plus Standard First-line Disease-Modifying Therapy | Experimental | Participants will receive standard first-line disease-modifying therapy plus terfenadine 60 mg orally once daily at bedtime for 1 month, followed by observation through 12 months. Receives: Drug: Terfenadine; Drug: Standard First-line Disease-Modifying Therapy |
| Standard First-line Disease-Modifying Therapy Alone | Active comparator | Participants will receive standard first-line disease-modifying therapy alone according to routine clinical practice and will be followed for 12 months. Receives: Drug: Standard First-line Disease-Modifying Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 1 month
Secondary outcomes (18)
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.
Measured: Baseline through 12 months
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.
Measured: Baseline, Month 1, and Month 12
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.
Measured: Baseline, Month 1, and Month 12
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.
Measured: Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid oligoclonal bands (OCB)
Cerebrospinal fluid oligoclonal bands (OCB) will be assessed at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
Measured: Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid kappa free light chain (kFLC)
Cerebrospinal fluid kappa free light chain (kFLC) level will be measured at baseline, Month 1, and Month 12 in mg/L, and the change from baseline will be evaluated.
Measured: Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid IgG index
Cerebrospinal fluid IgG index will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
Measured: Baseline, Month 1, and Month 12
Change from baseline in serum neurofilament light chain (NfL)
Serum neurofilament light chain (NfL) levels will be measured at baseline and during follow-up. Changes in serum NfL from baseline will be evaluated at Month 1, Month 3, Month 6, and Month 12.
Measured: Baseline, Month 1, Month 3, Month 6, and Month 12
Change from baseline in Expanded Disability Status Scale (EDSS) score
Neurological disability will be assessed using the Expanded Disability Status Scale (EDSS), which ranges from 0 to 10, with higher scores indicating greater disability and a worse outcome. The change in EDSS score from baseline will be evaluated at Month 1, Month 6, and Month 12.
Measured: Baseline, Month 1, Month 6, and Month 12
Change from baseline in Timed 25-Foot Walk (T25FW) walking speed
Walking function will be assessed using the Timed 25-Foot Walk (T25FW). The change in T25FW walking speed from baseline will be evaluated at Month 3, Month 6, and Month 12.
Measured: Baseline, Month 3, Month 6, and Month 12
Change from baseline in Nine-Hole Peg Test (9HPT) completion time
Upper limb motor function will be assessed using the Nine-Hole Peg Test (9HPT). The change in the time required to complete the 9HPT from baseline will be evaluated at Month 3, Month 6, and Month 12.
Measured: Baseline, Month 3, Month 6, and Month 12
Change from baseline in Symbol Digit Modalities Test (SDMT) score
Cognitive function will be assessed using the Symbol Digit Modalities Test (SDMT), which ranges from 0 to 110, with higher scores indicating better cognitive processing speed. The change in SDMT score from baseline will be evaluated at Month 6 and Month 12.
Measured: Baseline, Month 6, and Month 12
Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score
Overall functional status will be assessed using the Multiple Sclerosis Functional Composite (MSFC), a standardized composite measure of neurological function based on the Timed 25-Foot Walk, 9-Hole Peg Test, and Paced Auditory Serial Addition Test. The MSFC score is expressed as a standardized z-score, with higher scores indicating better functional performance. The change in MSFC score from baseline will be evaluated at Month 6 and Month 12.
Measured: Baseline, Month 6, and Month 12
Change from baseline in EQ-5D-5L score
Health-related quality of life will be assessed using the 5-Level EuroQol 5-Dimension questionnaire (EQ-5D-5L). The descriptive system consists of five dimensions, each rated from 1 to 5, with higher dimension scores indicating more severe problems. The EQ-5D-5L responses may be converted to an index value using the applicable value set, with higher index values indicating better health-related quality of life. The change in EQ-5D-5L score from baseline will be evaluated at Month 1 and Month 12.
Measured: Baseline, Month 1, and Month 12
Confirmed disability progression (CDP) rate at Month 6
Confirmed disability progression will be evaluated at Month 6. CDP will be defined as an increase in EDSS score of at least 1.0 point for participants with a baseline EDSS score of 5.5 or lower, or at least 0.5 point for participants with a baseline EDSS score greater than 5.5, or an increase of at least 20% in T25FW completion time or 9HPT completion time.
Measured: Baseline to Month 6
Annualized relapse rate at Month 12
Disease relapse will be assessed throughout the study, and the annualized relapse rate will be evaluated through Month 12. The annualized relapse rate at Month 12 will be compared between the terfenadine treatment group and the active comparator group.
Measured: Baseline through Month 12
MRI T2 lesion activity at Month 12
Brain and spinal cord MRI findings will be evaluated at Month 12. The assessment will include the number of new or enlarging T2 hyperintense lesions, changes from baseline in cumulative T2 lesion number and lesion volume, and the proportion of participants without new T2 hyperintense lesions.
Measured: Baseline and Month 12
Gadolinium-enhancing T1 lesions on brain MRI at Month 12
Brain MRI findings will be evaluated at Month 12. The assessment will include the change from baseline in the number of gadolinium-enhancing T1 lesions and the proportion of participants without gadolinium-enhancing lesions.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Aug 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, open-label, randomized, parallel-group controlled clinical trial. Participants will be randomly assigned in a 2:1 ratio to receive either terfenadine plus standard first-line disease-modifying therapy or standard first-line disease-modifying therapy alone.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuan Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuan Qin, Tongji Hospital
- Investigators
- Chuan Qin, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827716
- Sponsor's protocol ID
- TJ-IRB202607023
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the study data are intended for analysis by the research team and publication of the study results only.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07827716
- Acronym / sponsor ID
- TJ-IRB202607023
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Terfenadine, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Disease-Modifying Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chuan QinUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system that can cause neurological disability and disease progression. Current disease-modifying therapies can reduce relapses and MRI disease activity, but limitations remain in preventing disability progression and promoting remyelination or neuroprotection.
Terfenadine is a histamine H1 receptor antagonist. Preclinical evidence suggests that histamine signaling may be involved in immune and inflammatory processes relevant to MS. This study will evaluate the safety and tolerability of terfenadine as an adjunct to standard first-line disease-modifying therapy and explore its potential clinical effects in people with MS.
This is a single-center, open-label, randomized controlled clinical trial. Approximately 100 participants will be enrolled and randomly assigned in a 2:1 ratio to a terfenadine treatment group or a control group. Participants in the terfenadine group will receive terfenadine 60 mg orally once daily at bedtime for 1 month in addition to standard first-line disease-modifying therapy. Participants in the control group will receive standard first-line disease-modifying therapy alone.
Participants will be followed for 12 months. Study assessments will include physical examinations, vital signs, laboratory tests, electrocardiograms, imaging examinations, neurological and functional assessments, quality-of-life assessments, and collection of blood, stool, and cerebrospinal fluid samples at scheduled visits. Safety will be assessed throughout the study by recording and following adverse events and by reviewing relevant clinical and laboratory findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, open-label, randomized, parallel-group controlled clinical trial. Participants will be randomly assigned in a 2:1 ratio to receive either terfenadine plus standard first-line disease-modifying therapy or standard first-line disease-modifying therapy alone.
| Arm | Type | Receives |
|---|---|---|
| Terfenadine Plus Standard First-line Disease-Modifying Therapy | Experimental | Drug: Terfenadine, Drug: Standard First-line Disease-Modifying TherapyParticipants will receive standard first-line disease-modifying therapy plus terfenadine 60 mg orally once daily at bedtime for 1 month, followed by observation through 12 months. |
| Standard First-line Disease-Modifying Therapy Alone | Active comparator | Drug: Standard First-line Disease-Modifying TherapyParticipants will receive standard first-line disease-modifying therapy alone according to routine clinical practice and will be followed for 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- Secondary demyelinating diseases of the central nervous system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerfenadineTerfenadine 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. | Drug | Terfenadine Plus Standard First-line Disease-Modifying Therapy |
| Standard First-line Disease-Modifying TherapyParticipants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice. | Drug | Standard First-line Disease-Modifying Therapy Alone, Terfenadine Plus Standard First-line Disease-Modifying Therapy |
Primary outcome
Safety and tolerability of terfenadine during the treatment period
Time frame: Baseline through 1 month
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.
18 secondary outcomes
Safety and tolerability during the 12-month follow-up period
Time frame: Baseline through 12 months
Change from baseline in cerebrospinal fluid white blood cell count
Time frame: Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid albumin quotient
Time frame: Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid neurofilament light chain (NfL)
Time frame: Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid oligoclonal bands (OCB)
Time frame: Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid kappa free light chain (kFLC)
Time frame: Baseline, Month 1, and Month 12
Change from baseline in cerebrospinal fluid IgG index
Time frame: Baseline, Month 1, and Month 12
Change from baseline in serum neurofilament light chain (NfL)
Time frame: Baseline, Month 1, Month 3, Month 6, and Month 12
Change from baseline in Expanded Disability Status Scale (EDSS) score
Time frame: Baseline, Month 1, Month 6, and Month 12
Change from baseline in Timed 25-Foot Walk (T25FW) walking speed
Time frame: Baseline, Month 3, Month 6, and Month 12
Change from baseline in Nine-Hole Peg Test (9HPT) completion time
Time frame: Baseline, Month 3, Month 6, and Month 12
Change from baseline in Symbol Digit Modalities Test (SDMT) score
Time frame: Baseline, Month 6, and Month 12
Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score
Time frame: Baseline, Month 6, and Month 12
Change from baseline in EQ-5D-5L score
Time frame: Baseline, Month 1, and Month 12
Confirmed disability progression (CDP) rate at Month 6
Time frame: Baseline to Month 6
Annualized relapse rate at Month 12
Time frame: Baseline through Month 12
MRI T2 lesion activity at Month 12
Time frame: Baseline and Month 12
Gadolinium-enhancing T1 lesions on brain MRI at Month 12
Time frame: Baseline and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the study data are intended for analysis by the research team and publication of the study results only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chuan Qin principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terfenadine and Standard First-line Disease-Modifying Therapy in people with Relapsing Remitting Multiple Sclerosis, run by Chuan Qin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lian Chen (+8617371539505, chenlian318@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of terfenadine during the treatment period (time frame: Baseline through 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.