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

NCT07843108 | Active Not Recruiting Phase 1

• 3 other identifiers: Rimohandopen2025-524279-22-002025
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

cervical spinal cord injury; hand function; fatigue

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of study treatment (day 0) until end of follow-up (day 120).

Secondary Outcomes (22)

• Six-Minute Walk Test (6MWT).

  Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

• Ten-Meter Walk Test (10MWT).

  Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

• Berg Balance Scale (BBS).

  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).

  Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

• Finger Tapping Test (FTT).

  From start of study treatment (day 0) until end of follow-up (day 120).

Other Outcomes (9)

• Columbia-Suicide Severity Rating Scale (C-SSRS).

  Baseline, visit 03 (day 30), visit 05 (day 60) and visit 06 (day 90).

• Adverse Events (AEs).

  Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

• Serious Adverse Events (SAEs).

  Baseline, visit 03 (day 30), visit 05 (day 60), visit 06 (day 90) and follow-up (day 120).

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Rimonabant

Interventions

Rimonabant DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Sinfatin S.L: lead

Study Sites (1)

Hospital Nacional de Parapléjicos

Toledo, Toledo, Spain

Location

MeSH Terms

Conditions

Fatigue

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: September 25, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

ES (1)