Status:
COMPLETED
Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Lead Sponsor:
Hospital Nacional de Parapléjicos de Toledo
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be t...
Detailed Description
Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be t...
Eligibility Criteria
Inclusion
- Traumatic spinal cord injury
- Incomplete lesion (AIS D)
- Neurological level between C4 and L1
- Chronic stage (\>1 year since injury)
- Preserved walking ability for at least 5 m (aid allowed)
- Psychiatric assessment to exclude individuals with high suicide risk
- Capability to provide informed consent
- For fertile women, possibility to use anti conceptive methods
Exclusion
- Non traumatic spinal cord injury
- AIS A, B, C or E
- Neurological level above C4 or below L1
- Subacute stage (\<1 year since injury)
- Preserved walking ability for less than 5 m (aid allowed)
- Pregnancy or breast feeding
- For fertile women, impossibility to use anti conceptive methods
- Anticoagulant treatment
- Hypothyroidism
- Severe kidney or liver dysfunction
- Severe depression
- Fatigue treatment in the last 6 months
- Impossibility to reach the Hospital
- Impossibility to provide informed consent
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05398913
Start Date
May 12 2021
End Date
June 7 2022
Last Update
November 15 2022
Active Locations (1)
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1
Hospital Nacional de Paraplejicos
Toledo, Spain, 45004