Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury

Phase 2Active Not RecruitingNCT07843108

Sinfatin S.L8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Spinal Cord Injury

Interventions

RimonabantDRUG

Two tablets of rimonabant 2.5 mg (5 mg per day).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 and 75 years. 2. At least 2 months since spinal cord injury. 3. Cervical spinal cord injury (C1-C8) with AIS A-D. 4. Muscle strength should be within a range of 5 to 40 points on the UEMS score. 5. Capacity to provide informed consent. Exclusion 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/m². 5. 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 with pharmacological intervention 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. 12. 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.

Locations (1)

Hospital Nacional de Parapléjicos

Toledo, Toledo, Spain

Outcomes

Primary Outcomes

Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).

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.

Time frame: From start of study treatment (day 0) until end of follow-up (day 120).

Secondary Outcomes

Six-Minute Walk Test (6MWT).

The Six-Minute Walk Test (6MWT) assesses functional walking capacity and endurance by measuring the total distance the participant is able to walk during six minutes. Greater distance walked indicates better walking endurance and functional capacity

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Ten-Meter Walk Test (10MWT).

The Ten-Meter Walk Test (10MWT) assesses walking performance by measuring the time required to walk 10 meters at a comfortable or maximal pace. Shorter completion times indicate faster walking performance. Walking speed over 10 meters is reported in meters/second.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Berg Balance Scale (BBS).

The Berg Balance Scale comprises 14 tasks scored from 0 to 4. Total scores range from 0 to 56; higher scores indicate better balance.

Time frame: 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).

Assesses walking ability according to physical assistance, braces and assistive devices. Scores range from 0 to 20; higher scores indicate greater walking independence.

Data from ClinicalTrials.gov

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Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Finger Tapping Test (FTT).

Motor speed and coordination are assessed as the number of finger taps completed during the predefined test interval. Higher values indicate better motor speed/performance.

Time frame: From start of study treatment (day 0) until end of follow-up (day 120).

Box and Block Test (BBT).

Gross manual dexterity is assessed as the number of blocks transferred between compartments in 60 seconds. Higher values indicate better manual dexterity.

Time frame: From start of study treatment (day 0) until end of follow-up (day 120).

Nine-Hole Peg Test (9HPT).

Fine manual dexterity is assessed as the time, in seconds, required to place and remove nine pegs. Lower completion times indicate better manual dexterity.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Dynamometry.

Maximum handgrip force is measured using a handheld dynamometer. Higher values indicate greater handgrip strength.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Upper Extremity Motor Score (UEMS).

UEMS evaluates five key upper-limb muscle groups bilaterally, each scored from 0 to 5. Total score ranges from 0 to 50; higher scores indicate greater upper-limb motor strength.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Functional Reach Test (FRT).

Measures the maximum forward reaching distance without loss of stability. Higher values indicate greater functional reach and dynamic balance.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Borg Category-Ratio 10 (Borg CR10).

Perceived exertion is assessed using the Borg CR10 Scale. Scores range from 0 to 10, with higher scores indicating greater perceived exertion/fatigue.

Time frame: From start of study treatment (day 0) until end of follow-up (day 120).

Visual Analogue Scale for Fatigue (VAS-F).

Used to assess the participant's subjective perception of fatigue intensity. Participants rate their perceived fatigue following the Finger Tapping Test (FTT). Scores range from 0 to 10, with higher scores indicating greater perceived fatigue. Changes from baseline will be evaluated during treatment and follow-up.

Time frame: From start of study treatment (day 0) until end of follow-up (day 120).

Fatigue Severity Scale (FSS).

To evaluates fatigue severity. Scores ≥ 4 indicate clinically significant fatigue.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Multidimensional Fatigue Inventory (MFI-20).

Measures five dimensions of fatigue, offering a comprehensive assessment of fatigue impact.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Breathing test.

To assess the participant's respiratory function and lung capacity.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Oximetry.

Non-invasively measures blood oxygen saturation and heart rate

Time frame: From start of study treatment (day 0) until end of follow-up (day 120).

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).

The ISNCSCI are systematically assesses motor and sensory function to detemine the neurological level and completenees of spinal cord injury.

Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120)

Motor Evoked Potentials (MEPs).

Transcranial magnetic stimulation (TMS) is used to assess corticospinal excitability and motor pathway integrity by recording motor evoked potentials (MEPs). Changes in MEPs from baseline will be assessed throughout treatment and follow-up.

Time frame: From start of study treatment (day 0) until end of follow-up (day 120).

Somatosensory Evoked Potentials (SEPs).

Somatosensory evoked potentials (SEPs) are recorded following peripheral nerve electrical stimulation to assess sensory pathway conduction and integrity through cortical responses.

Time frame: From start of study treatment (day 0) until end of follow-up (day 120).

Spinal Cord Independence Measure III (SCIM-III).

The Spinal Cord Independence Measure III (SCIM-III) assesses functional independence in activities of daily living, mobility, and sphincter management and provides an overall measure of functional recovery. Higher scores indicate greater functional independence.

Time frame: 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).

The Medical Outcomes Study Sleep Scale (MOS-SS) assesses multiple aspects of sleep during the previous four weeks, including sleep quality, sleep disturbances, somnolence, and sleep adequacy.

Time frame: 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).

The Patient Global Impression of Change (PGIC) assesses the participant's subjective perception of overall improvement or deterioration since the beginning of the study.

Time frame: Visit 03 (day 30), visit 06 (day 90) and follow-up (day 120)