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.
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. Main goal is to test safety of Rimonabant in a specific population (incomplete spinal cord injury).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Rimonabant
Hospital Nacional de Paraplejicos
Toledo, Spain
Adverse events (safety)
number of AE
Time frame: 150 days
6 min walking test (efficacy)
6 min walking test (meters and number of stops are reported)
Time frame: 5 days
Biochemical and urine analysis (safety)
Number of participants with clinically significant abnormal laboratory tests results
Time frame: 8 days
ECG (safety)
Number of participants with clinically significant abnormal ECG readings
Time frame: 8 days
Beck Depression Inventory (BDI) (safety)
Range 0-63 (higher values more severe)
Time frame: 15 days
Hospital Anxiety and Depression Scale (HAD) (safety)
Range 0-21(higher values more severe)
Time frame: 15 days
Modified Ashworth Scale (safety)
Range 0-4 (higher values more severe)
Time frame: 15 days
Penn Scale (safety)
Range 0-4 (higher values more severe)
Time frame: 15 days
10 m test (efficacy)
Time to walk 10 m (no stops are allowed)
Time frame: 5 days and 15 days
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6 min walking test (efficacy)
6 min walking test (meters and number of stops are reported)
Time frame: 15 days
Borg Scale (efficacy)
Borg Scale punctuation after 6 min waking test. Range 0-10.
Time frame: 5 days and 15 days
WISCI II (efficacy)
Range 0-20 (higher values less severe)
Time frame: 5 and 15 days
Motor Score (efficacy)
Motor Score (ISNCSCI). Range 0-20 (higher values less severe)
Time frame: 8 days
Fatigue Severity Scale (FSS) (Efficacy)
FSS puntuación. Range 0-7 (higher values more severe)
Time frame: 5 and 15 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: 8 days
Patient global impression of changes (PGIC) (efficacy)
PGIG score. Range 1-7 (higher values indicate worsening)
Time frame: 5 and 15 days
Pain numeric rating scale
Range 0-10 (higher values more severe)
Time frame: 8 days
Health state visual analogically scale
Range 0-100 mm (higher values indicate higher health state )
Time frame: 8 days