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NCT05622994
Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Conditions: Spinal Cord Injuries
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE2
Enrollment: 80
Sponsor: Hospital Nacional de Parapléjicos de Toledo
Location: Spain
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.
Eligibility Criteria
Inclusion Criteria:Age >18 yo and <75yoNon progressive spinal cord injuryIncomplete lesion (AIS C or D)Neurological level between C4 and L1Chronic stage (>1 year since injury)Preserved walking ability for at least 5 m (aid allowed)Capability to provide informed consentFor fertile women, possibility to use anti conceptive methodsExclusion Criteria:Age <18 yo or >75AIS A, B or ENeurological level above C4 or below L1Subacute stage (<1 year since injury)Preserved walking ability for less than 5 m (aid allowed)Pregnancy or breast feedingFor fertile women, impossibility to use anti conceptive methodsanticoagulant treatmentHypothyroidismSevere bone, kidney or liver disfunctionImpossibility to reach the hospitalImpossibility to rovide informed consent
Source: ClinicalTrials.gov (NCT05622994). StuddyBuddy aggregates publicly available trial information.
