Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
- Registration Number
- NCT05622994
- Lead Sponsor
- Hospital Nacional de Parapléjicos de Toledo
- Brief 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.
- Detailed 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rimonabant Rimonabant Rimonabant 5mg Placebo Rimonabant Placebo
- Primary Outcome Measures
Name Time Method Questionnaire of falls (safety) 120 days Number of falls
ECG (safety) 120 days Number of participants with clinically significant abnormal ECG readings
Biochemical and urine analysis (safety) 120 days Number of participants with clinically significant abnormal laboratory tests results
Modified Ashworth Scale (safety) 90 days Range 0-4 (higher values more severe)
Penn Scale (safety) 90 days Range 0-4 (higher values more severe)
Adverse Events (Safety) 120 days Number of AE
Pain numeric rating scale (safety) 90 days Range 0-10 (higher values more severe)
Hospital Anxiety and Depression Scale (HAD) (safety 120 days Range 0-21(higher values more severe)
6 min walking test (efficacy) 90 days 6 min walking test (meters and number of stops are reported)
- Secondary Outcome Measures
Name Time Method 10 m test (efficacy) 90 days Time to walk 10 m (no stops are allowed)
Patient global impression of changes (PGIC) (efficacy) 90 days PGIG score. Range 1-7 (higher values indicate worsening)
Health state visual analogically scale (efficacy) 90 days Range 0-100 mm (higher values indicate higher health state )
Fatigue Severity Scale (FSS) (Efficacy) 90 days FSS puntuación. Range 0-7 (higher values more severe)
Borg Scale (efficacy) 90 days Borg Scale punctuation after 6 min waking test. Range 0-10.
Motor Score (efficacy) 90 days Motor Score (ISNCSCI). Range 0-20 (higher values less severe)
European Quality of Life -5 Dimensions (EQ-5D) (efficacy) 90 days EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 3 problem levels corresponding to patient response choices (higher values worst). A quality-of-life score is obtained according to the answers to the questionnaires (algorithm to calculate the score in euroqol.org). The maximum score is 1 that indicates excellent quality of life (range for Spanish version 0.5-1).
Spinal Cord Independence Measures, SCIM (efficacy) 90 days Range 0-100 (higher values indicate higher independence )
Trial Locations
- Locations (1)
Hospital Nacional de Paraplejicos
🇪🇸Toledo, Spain