Exploratory study on the effect of Rimonabant on hand function in patients with spinal cord injury (RIMOHANDOPEN)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sinfatin S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11], Diseases [C] - Nervous System Diseases [C10]

Trial duration

22 May 2026 → ongoing

Decision date (initial)

2026-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of rimonabant in improving hand motor function in patients with cervical spinal cord injury, using the Graded Assessment of Strength, Sensation and Prehension (GRASSP) scale.

Secondary objectives 1

1. 1) To evaluate the effect of rimonabant on neuronal excitability in the study population. 2) To assess the effect of treatment on motor and functional performance. 3) To evaluate the effect of treatment on fatigue and quality of life. 4) To assess the safety and tolerability of rimonabant through clinical evaluations and the analysis of adverse events

Conditions and MedDRA coding

Spinal cord injury

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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 12

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
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
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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 31

1. 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
2. 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
3. Berg Balance Scale (BBS): evaluates static and dynamic balance through 14 functional tasks, providing a quantitative assessment of fall risk and postural control
4. 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.
5. Finger Tapping Test (FTT): measures motor speed and coordination by recording the number of finger taps within a set time period
6. Box and Block Test (BBT): assesses gross manual dexterity by counting the number of blocks transferred from one compartment to another in 60 seconds
7. 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
8. Dynamometry: measures handgrip strength by recording the maximum force exerted during a grip using a handheld dynamometer.
9. Upper Extremity Motor Score (UEMS): evaluates motor strength of five key upper limb muscles bilaterally. This data is obtained from the ISNCSCI scale
10. 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
11. Borg CR10 Scale: assesses perceived exertional fatigue immediately after the 6MWT and FTT, providing a subjective measure of effort intensity
12. Visual Analogue Scale for Fatigue (VAS-F): assesses perceived fatigue intensity by having participants rate their level of fatigue after FTT
13. Fatigue Severity Scale (FSS): evaluates fatigue severity over the previous week. Scores ≥ 4 indicate clinically significant fatigue
14. Multidimensional Fatigue Inventory (MFI-20): measures five dimensions of fatigue, offering a comprehensive assessment of fatigue impact
15. Breathing test: test designed to evaluate the respiratory function and lung capacity of the participant.
16. Oximetry: non-invasively measures blood oxygen saturation and heart rate, providing a quick indicator of the participant's respiratory status
17. Heart rate: non-invasive measurement used to monitor cardiovascular response and detect potential abnormalities in heart function.
18. Blood pressure (systolic and diastolic): non-invasive assessment providing key information on vascular resistance and overall cardiovascular health.
19. 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
20. Transcranial magnetic stimulation (TMS): evaluate corticospinal excitability and motor pathway integrity registering motor evoked potentials (MEPs).
21. Somatosensory evoked potentials (SEPs) via electrical stimulation: assess sensory pathway conduction and integrity by recording cortical responses to peripheral nerve electrical stimulation.
22. 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.
23. Medical Outcomes Study Sleep Scale (MOS-SS): assesses multiple aspects of sleep, including quality, disturbances, somnolence, and adequacy, over the previous four weeks.
24. Patient Global Impression of Change (PGIC): captures the patient’s subjective perception of overall improvement or deterioration since the beginning of the study.
25. Recording and assessment of adverse events (AEs) occurring during treatment, serious adverse events (SAEs), and adverse events of special interest (AESIs).
26. Clinically significant changes in physical examination, biochemical parameters, vital signs.
27. Clinically significant changes in subjective pain perception, assessed using the Visual Analogue Scale (VAS-P).
28. Clinically significant changes in the level of muscle spasticity, assessed using the Modified Ashworth Scale (MAS).
29. Clinically significant changes in the frequency of muscle spasms, assessed using the Penn Spasm Frequency Scale (PSFS).
30. 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).
31. Suicide risk, assessed using C-SSRS.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sinfatin S.L.

Sponsor organisation

Sinfatin S.L.

Address

Cuesta De Carlos V 4

City

Toledo

Postcode

45001

Country

Spain

Scientific contact point

Organisation

Sinfatin S.L.

Contact name

Eloy Roberto Ferreras Puente

Public contact point

Organisation

Sinfatin S.L.

Contact name

Eloy Roberto Ferreras Puente

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications