Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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 tested using six-min walking test.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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