A Phase 1/2 interventional study of Rimonabant in Cervical Spinal Cord Injury, sponsored by Sinfatin S.L. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Sinfatin S.L · Phase 1/2, Interventional, and Treatment
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.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's planned enrollment of 8 is below the median of 54 across 1,757 interventional studies indexed under Fatigue.
Browse Fatigue studies →Sinfatin S.L is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Fertile men or women who cannot guarantee the use of highly effective 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 , 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will receive two tablets of rimonabant 2.5 mg (total of 5 mg), once daily for 90 days
Drug: Rimonabant
Two tablets of rimonabant 2.5 mg (5 mg per day).
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).
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.
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)
Columbia-Suicide Severity Rating Scale (C-SSRS).
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
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60) and visit 06 (day 90).
Adverse Events (AEs).
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.
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).
Serious Adverse Events (SAEs).
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.
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).
Adverse Events of Special Interest (AESIs).
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.
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).
The Visual Analogue Scale for Pain (VAS-P).
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.
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).
Modified Ashworth Scale (MAS).
Is used to assess changes in muscle spasticity during the study. Higher grades indicate greater muscle tone/spasticity
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).
The Penn Spasm Frequency Scale (PSFS).
Is used to assess changes in the frequency of muscle spasms during the study. Higher scores indicate a greater frequency of muscle spasms.
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).
Beck Depression Inventory-II (BDI-II).
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.
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).
Hospital Anxiety and Depression Scale (HADS).
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.
Time frame: Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rimonabant
Sinfatin S.L