RIMONABANT for Spinal cord injury|Cervical spinal cord injury

Inclusion criteria

• {"criterion_text":"- Age between 18 and 75 years\n- At least 2 months since spinal cord injury\n- Cervical spinal cord injury (C1–C8) with AIS A–D\n- Muscle strength should be within a range of 5 to 40 points on the UEMS score\n- Capacity to provide informed consent"}

Exclusion criteria

• {"criterion_text":"- High suicide risk assessed by C-SSRS\n- Participation in another clinical trial with pharmacological intervention within the month prior to enrolment\n- 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\n- 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\n- History of severe psychiatric disorders, major depression or prior suicide attempts\n- Treatment with anticoagulants or strong CYP3A4 inhibitors or inducers\n- Body Mass Index (BMI) > 40 kg/m²\n- Pregnancy or breastfeeding\n- 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\n- Uncontrolled hypothyroidism, or a history of severe bone, liver, or kidney disease\n- Inability to attend hospital visits\n- Known allergy to rimonabant or any of the excipients used"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is defined as the change in the total GRASSP score, or in any of its three dimensions, between baseline and the end of rimonabant treatment.","definition_or_measurement_approach":"Change in total GRASSP score (or any of its three dimensions) between baseline and end of rimonabant treatment measured using the Graded Assessment of Strength, Sensation and Prehension (GRASSP) scale."}

Secondary endpoints

• {"endpoint_text":"- 6-Minute Walk Test (6MWT): measures the distance a participant can walk in six minutes, providing an index to measure fatigue, endurance and functional walking capacity\n- 10-Meter Walk Test (10MWT): measures the time taken to walk 10 meters at a comfortable or maximal pace, used to assess motor function through walking speed, fatigue and endurance\n- Berg Balance Scale (BBS): evaluates static and dynamic balance through 14 functional tasks, providing a quantitative assessment of fall risk and postural control\n- Walking Index for Spinal Cord Injury II (WISCI-II): assesses walking ability based on the level of assistance, use of assistive devices and need for support, yielding a score reflecting functional ambulation capacity.\n- Finger Tapping Test (FTT): measures motor speed and coordination by recording the number of finger taps within a set time period\n- Box and Block Test (BBT): assesses gross manual dexterity by counting the number of blocks transferred from one compartment to another in 60 seconds\n- Nine-Hole Peg Test (9HPT): measures fine manual dexterity by timing how long it takes to place and remove nine pegs from a boardNine-Hole Peg Test (9HPT): measures fine manual dexterity by timing how long it takes to place and remove nine pegs from a board\n- Dynamometry: measures handgrip strength by recording the maximum force exerted during a grip using a handheld dynamometer.\n- Upper Extremity Motor Score (UEMS): evaluates motor strength of five key upper limb muscles bilaterally. This data is obtained from the ISNCSCI scale\n- Functional Reach Test (FRT): assesses upper limb functional reach and dynamic balance by measuring the maximum distance an individual can reach forward without losing stability\n- Borg CR10 Scale: assesses perceived exertional fatigue immediately after the 6MWT and FTT, providing a subjective measure of effort intensity\n- Visual Analogue Scale for Fatigue (VAS-F): assesses perceived fatigue intensity by having participants rate their level of fatigue after FTT\n- Fatigue Severity Scale (FSS): evaluates fatigue severity over the previous week. Scores ≥ 4 indicate clinically significant fatigue\n- Multidimensional Fatigue Inventory (MFI-20): measures five dimensions of fatigue, offering a comprehensive assessment of fatigue impact\n- Breathing test: test designed to evaluate the respiratory function and lung capacity of the participant.\n- Oximetry: non-invasively measures blood oxygen saturation and heart rate, providing a quick indicator of the participant's respiratory status\n- Heart rate: non-invasive measurement used to monitor cardiovascular response and detect potential abnormalities in heart function.\n- Blood pressure (systolic and diastolic): non-invasive assessment providing key information on vascular resistance and overall cardiovascular health.\n- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI): determines the neurological level and completeness of spinal cord injury through systematic assessment of motor and sensory function\n- Transcranial magnetic stimulation (TMS): evaluate corticospinal excitability and motor pathway integrity registering motor evoked potentials (MEPs).\n- Somatosensory evoked potentials (SEPs) via electrical stimulation: assess sensory pathway conduction and integrity by recording cortical responses to peripheral nerve electrical stimulation.\n- Spinal Cord Independence Measure (SCIM-III): measures functional independence in activities of daily living, mobility, and sphincter management, providing an index of overall functional recovery.\n- Medical Outcomes Study Sleep Scale (MOS-SS): assesses multiple aspects of sleep, including quality, disturbances, somnolence, and adequacy, over the previous four weeks.\n- Patient Global Impression of Change (PGIC): captures the patient’s subjective perception of overall improvement or deterioration since the beginning of the study.\n- Recording and assessment of adverse events (AEs) occurring during treatment, serious adverse events (SAEs), and adverse events of special interest (AESIs).\n- Clinically significant changes in physical examination, biochemical parameters, vital signs.\n- Clinically significant changes in subjective pain perception, assessed using the Visual Analogue Scale (VAS-P).\n- Clinically significant changes in the level of muscle spasticity, assessed using the Modified Ashworth Scale (MAS).\n- Clinically significant changes in the frequency of muscle spasms, assessed using the Penn Spasm Frequency Scale (PSFS).\n- Clinically significant changes in mood, specifically depression and anxiety, assessed using the Beck Depression Inventory-II (BDI-II) and the Hospital Anxiety and Depression Scale (HADS).\n- Suicide risk, assessed using C-SSRS.","definition_or_measurement_approach":"Each secondary endpoint is measured as described alongside the endpoint: e.g., 6MWT = distance walked in six minutes; 10MWT = time to walk 10 meters; BBS = 14 functional tasks scoring balance; WISCI-II = walking ability based on assistance and devices; FTT = number of finger taps in set time; BBT = number of blocks moved in 60 seconds; 9HPT = time to place/remove nine pegs; Dynamometry = maximum handgrip force; UEMS = motor strength from ISNCSCI; FRT = maximal forward reach distance; Borg CR10 and VAS-F = subjective fatigue measures; FSS and MFI-20 = validated fatigue questionnaires; Breathing test/Oximetry/Heart rate/Blood pressure = physiological measures; ISNCSCI = neurological level/completeness assessment; TMS = motor evoked potentials to assess corticospinal excitability; SEPs = cortical responses to peripheral nerve stimulation; SCIM-III = functional independence score; MOS-SS = sleep scale; PGIC = patient global impression; Safety = recording AEs/SAEs/AESIs; other scales = MAS, PSFS, BDI-II, HADS, C-SSRS per descriptions in protocol."}

Spain

Earliest CTIS Part Ii Submission Date

11-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

42

Number Of Sites

1

Number Of Participants

8

Primary sponsor

Full Name

Sinfatin S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Samos Medical Enterprise S.L.","duties_or_roles":"sponsorDuties code 1","organisation_type":"Pharmaceutical company"}