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

This arm will receive two tablets of rimonabant 2.5 mg (total of 5 mg), once daily for 90 days

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

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.

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

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.

The Berg Balance Scale comprises 14 tasks scored from 0 to 4.

Total scores range from 0 to 56; higher scores indicate better balance.

Assesses walking ability according to physical assistance, braces and assistive devices.

Scores range from 0 to 20; higher scores indicate greater walking independence.

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.

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

Higher values indicate better manual dexterity.

Fine manual dexterity is assessed as the time, in seconds, required to place and remove nine pegs.

Lower completion times indicate better manual dexterity.

Maximum handgrip force is measured using a handheld dynamometer.

Higher values indicate greater handgrip strength.

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.

Measures the maximum forward reaching distance without loss of stability.

Higher values indicate greater functional reach and dynamic balance.

Perceived exertion is assessed using the Borg CR10 Scale.

Scores range from 0 to 10, with higher scores indicating greater perceived exertion/fatigue.

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.

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

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

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

Non-invasively measures blood oxygen saturation and heart rate

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

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.

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

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.

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.

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

Is used to monitor suicidal ideation and behavior. A suicidality alert is defined in the protocol as a positive C-SSRS response indicating suicidal ideation with intent, preparatory behavior, or suicide attempt. The outcome will report the number of participants meeting the protocol-defined suicidality criteria

Is an adverse event with onset after the first administration of rimonabant. The outcome will report the number of participants experiencing at least one TEAE. Events will be assessed for intensity, seriousness, and relationship to the investigational medicinal product and coded by System Organ Class and Preferred Term.

The outcome will report the number of participants experiencing at least one serious adverse event meeting the protocol-defined seriousness criteria, including death, life-threatening events, hospitalization or prolongation of hospitalization, significant disability or incapacity, congenital anomaly/birth defect, or other clinically important medical events.

The outcome will report the number of participants experiencing at least one protocol-defined adverse event of special interest. Particular attention is given to psychiatric events and clinically relevant changes in mental status because of the known psychiatric risk profile of rimonabant.

Assesses the participant's subjective perception of pain intensity. Changes from baseline will be used to identify clinically significant changes in pain during treatment and follow-up.

Is used to assess changes in muscle spasticity during the study. Higher grades indicate greater muscle tone/spasticity

Is used to assess changes in the frequency of muscle spasms during the study. Higher scores indicate a greater frequency of muscle spasms.

Is used to monitor depressive symptoms during the study. Higher scores indicate greater severity of depressive symptoms. According to the protocol, a score ≥20 triggers a moderate psychiatric alert and a score ≥29 triggers a high psychiatric alert requiring confirmation and specialist assessment.

The Hospital Anxiety and Depression Scale (HADS) assesses anxiety or depression symptoms. Higher scores indicate greater symptom severity. According to the protocol, a subscale score (either anxiety or depression) ≥11 triggers a moderate alert and ≥15 a high psychiatric alert.