Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury (RIMOFATSCI-2)

Hospital Nacional de Parapléjicos de Toledo

Status and phase: Not yet enrolling; Phase 2

Conditions: Spinal Cord Injuries

Treatments: Drug: Rimonabant

Study type: Interventional

Funder types: Other

Identifiers

NCT05622994

FHNP-CT003

Details and patient eligibility

About

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.

Full description

This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period.

Main goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) of Rimonabant in a specific population (incomplete spinal cord injury).

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Rimonabant

Active Comparator group

Description:

Rimonabant 5mg

Treatment:

Drug: Rimonabant

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Rimonabant