Cervical Spinal Cord InjuryPhase 1/2RIMOHANDOPENNCT07843108
Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury
A Phase 1/2 study testing Rimonabant in people with Cervical Spinal Cord Injury, run by Sinfatin S.L at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- Rimonabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2026to Aug 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study on the Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury (RIMOHANDOPEN)
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.
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- Rimonabant
- Keywords
- cervical spinal cord injury, hand function, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Two tablets of rimonabant 2.5 mg (5 mg per day).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This arm will receive two tablets of rimonabant 2.5 mg (total of 5 mg), once daily for 90 days Receives: Drug: Rimonabant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of study treatment (day 0) until end of follow-up (day 120).
Secondary outcomes (22)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 03 (day 30), visit 06 (day 90) and follow-up (day 120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start13 May 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinfatin S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843108
- Sponsor's protocol ID
- Rimohandopen
- Other IDs
- 2025-524279-22-00, 2025
- Acronym
- RIMOHANDOPEN
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No