A Study to Evaluate the Preliminary Efficacy and Safety of Terfenadine in Patients With Relapsing-Remitting Multiple Sclerosis
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Lian Chen
- 電話番号：+8617371539505
- メール：chenlian318@163.com
研究連絡先のバックアップ
- 名前：Shu Fan
- 電話番号：+8618732327876
- メール：shufan_fs@163.com
研究場所
-
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Hubei
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Wuhan、Hubei、中国、430030
- 募集
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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主任研究者：
- Daishi Tian
-
主任研究者：
- Chuan Qin
-
コンタクト：
- Lian Chen
- 電話番号：+8617371539505
- メール：chenlian318@163.com
-
コンタクト：
- Shu Fan
- 電話番号：+8618732327876
- メール：shufan_fs@163.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Terfenadine Plus Standard First-line Disease-Modifying Therapy
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.
|
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.
Participants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice.
|
|
アクティブコンパレータ：Standard First-line Disease-Modifying Therapy Alone
Participants will receive standard first-line disease-modifying therapy alone according to routine clinical practice and will be followed for 12 months.
|
Participants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and tolerability of terfenadine during the treatment period
時間枠：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.
|
Baseline through 1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and tolerability during the 12-month follow-up period
時間枠：Baseline through 12 months
|
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.
|
Baseline through 12 months
|
|
Change from baseline in cerebrospinal fluid white blood cell count
時間枠：Baseline, Month 1, and Month 12
|
Cerebrospinal fluid white blood cell count will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
|
Baseline, Month 1, and Month 12
|
|
Change from baseline in cerebrospinal fluid albumin quotient
時間枠：Baseline, Month 1, and Month 12
|
Cerebrospinal fluid albumin quotient will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
|
Baseline, Month 1, and Month 12
|
|
Change from baseline in cerebrospinal fluid neurofilament light chain (NfL)
時間枠：Baseline, Month 1, and Month 12
|
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.
|
Baseline, Month 1, and Month 12
|
|
Change from baseline in cerebrospinal fluid oligoclonal bands (OCB)
時間枠：Baseline, Month 1, and Month 12
|
Cerebrospinal fluid oligoclonal bands (OCB) will be assessed at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
|
Baseline, Month 1, and Month 12
|
|
Change from baseline in cerebrospinal fluid kappa free light chain (kFLC)
時間枠：Baseline, Month 1, and Month 12
|
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.
|
Baseline, Month 1, and Month 12
|
|
Change from baseline in cerebrospinal fluid IgG index
時間枠：Baseline, Month 1, and Month 12
|
Cerebrospinal fluid IgG index will be measured at baseline, Month 1, and Month 12, and the change from baseline will be evaluated.
|
Baseline, Month 1, and Month 12
|
|
Change from baseline in serum neurofilament light chain (NfL)
時間枠：Baseline, Month 1, Month 3, Month 6, and Month 12
|
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.
|
Baseline, Month 1, Month 3, Month 6, and Month 12
|
|
Change from baseline in Expanded Disability Status Scale (EDSS) score
時間枠：Baseline, Month 1, Month 6, and Month 12
|
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.
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Baseline, Month 1, Month 6, and Month 12
|
|
Change from baseline in Timed 25-Foot Walk (T25FW) walking speed
時間枠：Baseline, Month 3, Month 6, and Month 12
|
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.
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Baseline, Month 3, Month 6, and Month 12
|
|
Change from baseline in Nine-Hole Peg Test (9HPT) completion time
時間枠：Baseline, Month 3, Month 6, and Month 12
|
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.
|
Baseline, Month 3, Month 6, and Month 12
|
|
Change from baseline in Symbol Digit Modalities Test (SDMT) score
時間枠：Baseline, Month 6, and Month 12
|
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.
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Baseline, Month 6, and Month 12
|
|
Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score
時間枠：Baseline, Month 6, and Month 12
|
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.
|
Baseline, Month 6, and Month 12
|
|
Change from baseline in EQ-5D-5L score
時間枠：Baseline, Month 1, and Month 12
|
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.
|
Baseline, Month 1, and Month 12
|
|
Confirmed disability progression (CDP) rate at Month 6
時間枠：Baseline to 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.
|
Baseline to Month 6
|
|
Annualized relapse rate at Month 12
時間枠：Baseline through 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.
|
Baseline through Month 12
|
|
MRI T2 lesion activity at Month 12
時間枠：Baseline and 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.
|
Baseline and Month 12
|
|
Gadolinium-enhancing T1 lesions on brain MRI at Month 12
時間枠：Baseline and 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.
|
Baseline and Month 12
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Chuan Qin、Tongji Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- TJ-IRB202607023
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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