Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period. Objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Nacional de Parapléjicos de Toledo
• Treatments: Rimonabant

Criteria

Inclusion Criteria:

• Age >18 yo and <75yo

• Non progressive spinal cord injury

• Incomplete lesion (AIS C or D)

• Neurological level between C4 and L1

• Chronic stage (>1 year since injury)

• Preserved walking ability for at least 5 m (aid allowed)

• Capability to provide informed consent

• For fertile women, possibility to use anti conceptive methods

Exclusion Criteria:

• Age <18 yo or >75

• AIS A, B 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 bone, kidney or liver disfunction

• Impossibility to reach the hospital

• Impossibility to rovide informed consent