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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
Hospital Nacional de Paraplejicos
Toledo, Spain
Adverse Events (Safety)
Number of AE
Time frame: 120 days
Biochemical and urine analysis (safety)
Number of participants with clinically significant abnormal laboratory tests results
Time frame: 120 days
ECG (safety)
Number of participants with clinically significant abnormal ECG readings
Time frame: 120 days
Hospital Anxiety and Depression Scale (HAD) (safety
Range 0-21(higher values more severe)
Time frame: 120 days
Modified Ashworth Scale (safety)
Range 0-4 (higher values more severe)
Time frame: 90 days
Penn Scale (safety)
Range 0-4 (higher values more severe)
Time frame: 90 days
Pain numeric rating scale (safety)
Range 0-10 (higher values more severe)
Time frame: 90 days
Questionnaire of falls (safety)
Number of falls
Time frame: 120 days
6 min walking test (efficacy)
6 min walking test (meters and number of stops are reported)
Time frame: 90 days
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10 m test (efficacy)
Time to walk 10 m (no stops are allowed)
Time frame: 90 days
Borg Scale (efficacy)
Borg Scale punctuation after 6 min waking test. Range 0-10.
Time frame: 90 days
Motor Score (efficacy)
Motor Score (ISNCSCI). Range 0-20 (higher values less severe)
Time frame: 90 days
Fatigue Severity Scale (FSS) (Efficacy)
FSS puntuación. Range 0-7 (higher values more severe)
Time frame: 90 days
Patient global impression of changes (PGIC) (efficacy)
PGIG score. Range 1-7 (higher values indicate worsening)
Time frame: 90 days
European Quality of Life -5 Dimensions (EQ-5D) (efficacy)
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).
Time frame: 90 days
Health state visual analogically scale (efficacy)
Range 0-100 mm (higher values indicate higher health state )
Time frame: 90 days
Spinal Cord Independence Measures, SCIM (efficacy)
Range 0-100 (higher values indicate higher independence )
Time frame: 90 days