NCT07843108进行中（未招募）1 期
Exploratory Study on the Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury (RIMOHANDOPEN)
Sinfatin S.L1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2026年5月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).
研究概览
简要总结
This is an one arm study to be conducted in spinal cord injury patients. The goal of this clinical trial is to learn if rimonabant improves hand motor and performance function in patients with cervical spinal cord injury. It will also learn about the safety of rimonabant.
Participants will: Take 5 mg of rimonabant every day for 90 days. Visit the clinic once every 15-30 days for checkups and tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years.
- •At least 2 months since spinal cord injury.
- •Cervical spinal cord injury (C1-C8) with AIS A-D.
- •Muscle strength should be within a range of 5 to 40 points on the UEMS score.
- •Capacity to provide informed consent.
排除标准
- •High suicide risk assessed by C-SSRS.
- •History of severe psychiatric disorders, major depression or prior suicide attempts.
- •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).
- •Body Mass Index (BMI) > 40 kg/m².
- •Pregnancy or breastfeeding.
- •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.
- •Uncontrolled hypothyroidism, or a history of severe bone, liver, or kidney disease.
- •Inability to attend hospital visits.
- •Known allergy to rimonabant or any of the excipients used.
- •Participation in another clinical trial with pharmacological intervention within the month prior to enrolment.
- •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.
- •Contraindications for transcranial magnetic stimulation (TMS), such as metal implants in the head, pacemakers, epileptic seizures in the last two years, or other implanted electronic devices.
研究组 & 干预措施
Treatment
Experimental
This arm will receive two tablets of rimonabant 2.5 mg (total of 5 mg), once daily for 90 days
干预措施: Rimonabant (Drug)
结局指标
主要结局
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).
时间窗: From start of study treatment (day 0) until end of follow-up (day 120).
The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) evaluates upper-limb sensorimotor and prehension function. Five subtests are assessed for each upper limb: dorsal sensation (0-12), palmar sensation (0-12), strength (0-50), prehension ability (0-12), and prehension performance (0-30). The maximum score is 116 points per upper limb. Higher scores indicate better upper-limb sensorimotor and prehension function.
次要结局
- Oximetry.(From start of study treatment (day 0) until end of follow-up (day 120).)
- Six-Minute Walk Test (6MWT).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Ten-Meter Walk Test (10MWT).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Berg Balance Scale (BBS).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Walking Index for Spinal Cord Injury II (WISCI-II).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Finger Tapping Test (FTT).(From start of study treatment (day 0) until end of follow-up (day 120).)
- Box and Block Test (BBT).(From start of study treatment (day 0) until end of follow-up (day 120).)
- Nine-Hole Peg Test (9HPT).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Dynamometry.(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Upper Extremity Motor Score (UEMS).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Functional Reach Test (FRT).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Borg Category-Ratio 10 (Borg CR10).(From start of study treatment (day 0) until end of follow-up (day 120).)
- Visual Analogue Scale for Fatigue (VAS-F).(From start of study treatment (day 0) until end of follow-up (day 120).)
- Fatigue Severity Scale (FSS).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Multidimensional Fatigue Inventory (MFI-20).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Breathing test.(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120))
- Motor Evoked Potentials (MEPs).(From start of study treatment (day 0) until end of follow-up (day 120).)
- Somatosensory Evoked Potentials (SEPs).(From start of study treatment (day 0) until end of follow-up (day 120).)
- Spinal Cord Independence Measure III (SCIM-III).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Medical Outcomes Study Sleep Scale (MOS-SS).(Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).)
- Patient Global Impression of Change score (PGIC).(Visit 03 (day 30), visit 06 (day 90) and follow-up (day 120))
研究者
研究点 (1)
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