2025-521693-33-00招募中2 期
Effects of a CB1 Receptor Antagonist/Inverse Agonist (Rimonabant) on Walking Ability in Patients in the Chronic Phase of Stroke
Sinfatin S.L.6 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Endpoints: Safety and tolerability variables ● Incidence of SAEs and AESIs. ● Incidence of AEs. ● Physical examination, laboratory tests, ECG, and vital signs (temperature, blood pressure, and heart rate). ● Scales that assess spasticity (MAS), spasm (PSFS) and pain (VAS). ● Clinical scales for anxiety and depression (BDI-II and HADS). ● Number of falls and % of standing activity. ● Self-perceived mood.
研究概览
简要总结
To evaluate the efficacy of rimonabant in improving walking capacity in post-stroke patients in chronic phase through the 6MWT.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •To participate in the study, participants must meet all of the following criteria: 1) Age between 18 and 75 years. 2) More than 12 months since diagnosis of stroke (chronic phase). 3) Modified Rankin Scale score between 2 and
- •Ability to walk at least 5 meters with or without assistance. 5) Capacity to provide written informed consent. 6) Preserved cognitive functions to adequately comply with study assessments.
排除标准
- •To participate in the study, participants must not meet any of the following criteria: 1) High suicide risk assessed by C-SSRS. 2) History of severe psychiatric disorders, major depression or prior suicide attempts. 3) Treatment with anticoagulants or strong CYP3A4 inhibitors or inducers (inhibitors such as ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, or nefazodone, and inducers such as rifampicin, phenytoin, phenobarbital, carbamazepine, or St. John's Wort). 4) Body Mass Index (BMI) > 40 kg/m
- •Pregnancy or breastfeeding. 6) Fertile men or women who cannot guarantee the use of highly effective contraceptive methods, as defined by the European HMA-CTFG guidelines—i.e., those with a failure rate of less than 1 % per year when used consistently and correctly (1).A woman is considered fertile if she is physiologically capable of becoming pregnant, from menarche until postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A woman is considered postmenopausal after spontaneous amenorrhea for at least 12 consecutive months with no alternative medical cause. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to support the diagnosis in women not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is not sufficient. Acceptable highly effective contraceptive methods include: ● Combined hormonal contraception (containing estrogen and progestogen) associated with ovulation inhibition, administered orally, vaginally, or transdermal. ● Progestogen-only hormonal contraception associated with ovulation inhibition (oral, injectable, or implantable). ● Intrauterine device (IUD). ● Intrauterine hormone-releasing system (IUS). ● Bilateral tubal occlusion. ● Vasectomized partner: provided this is the participant’s sole sexual partner and the vasectomy has been medically confirmed as successful. ● Sexual abstinence: refraining from heterosexual intercourse during the entire treatment and follow-up period. 7) Uncontrolled hypothyroidism, or a history of severe bone, liver, or kidney disease. 8) Inability to attend hospital visits. 9) Known allergy to rimonabant or any of the excipients used. 10) Participation in another clinical trial within the month prior to enrolment. 11) Any other condition that, in the opinion of the investigator, makes the subject's participation in the study unrecommended, such as severe heart failure or uncontrolled diabetes.
研究组 & 干预措施
Rimonabant 5 mg ODT
Test
干预措施: Rimonabant 5 mg ODT (Drug)
Identical to the medicine tablets, but without the active ingredient
Placebo
干预措施: Identical to the medicine tablets, but without the active ingredient (Drug)
结局指标
主要结局
Endpoints: Safety and tolerability variables ● Incidence of SAEs and AESIs. ● Incidence of AEs. ● Physical examination, laboratory tests, ECG, and vital signs (temperature, blood pressure, and heart rate). ● Scales that assess spasticity (MAS), spasm (PSFS) and pain (VAS). ● Clinical scales for anxiety and depression (BDI-II and HADS). ● Number of falls and % of standing activity. ● Self-perceived mood.
Endpoints: Safety and tolerability variables ● Incidence of SAEs and AESIs. ● Incidence of AEs. ● Physical examination, laboratory tests, ECG, and vital signs (temperature, blood pressure, and heart rate). ● Scales that assess spasticity (MAS), spasm (PSFS) and pain (VAS). ● Clinical scales for anxiety and depression (BDI-II and HADS). ● Number of falls and % of standing activity. ● Self-perceived mood.
Efficacy variables Primary endpoint: ● Six-minute walking test (6MWT).
Efficacy variables Primary endpoint: ● Six-minute walking test (6MWT).
次要结局
- Efficacy variables:Secondary endpoints: ● Borg CR10 Scale (post 6MWT). ● Gait speed via Ten-Meter Walk Test (10MWT). ● Fatigue Severity Scale (FSS). ● Multidimensional Fatigue Inventory (MFI-20). ● Stroke Impact Scale (SIS 3.0). ● Patient Global Impression of Change (PGIC). ● Health-related quality of life via EQ-5D-5L questionnaire.
研究者
Eloy Ferreras
Scientific
Sinfatin S.L.
研究点 (6)
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