Active, not recruiting
Phase 1/2
Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury
Condition(s) studied
Cervical Spinal Cord Injury
Investigational drug(s) / intervention(s)
Rimonabant
Rimonabant: Two tablets of rimonabant 2.5 mg (5 mg per day).
Study 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.
Eligibility
Inclusion Criteria:
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:
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 (inhibitors such as ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, or nefazodone, and inducers such as rifampicin, phenytoin, phenobarbital, carbamazepine, or St. John's Wort).
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 (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.
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.
Primary outcome measure(s)
- Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP). — From start of study treatment (day 0) until end of follow-up (day 120).
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.
Trial sites (1)
| Facility | City | Region | Status |
| Hospital Nacional de Parapléjicos |
Toledo |
Toledo |
|