Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Drug: Rimonabant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo controlled parallel design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rimonabant<br>Rimonabant 5mg | Drug: Rimonabant<br>* Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Rimonabant<br>* Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (Safety) | Number of AE | 120 days | 
| Biochemical and urine analysis (safety) | Number of participants with clinically significant abnormal laboratory tests results | 120 days | 
| ECG (safety) | Number of participants with clinically significant abnormal ECG readings | 120 days | 
| Hospital Anxiety and Depression Scale (HAD) (safety | Range 0-21(higher values more severe) | 120 days | 
| Modified Ashworth Scale (safety) | Range 0-4 (higher values more severe) | 90 days | 
| Penn Scale (safety) | Range 0-4 (higher values more severe) | 90 days | 
| Pain numeric rating scale (safety) | Range 0-10 (higher values more severe) | 90 days | 
| Questionnaire of falls (safety) | Number of falls | 120 days | 
| 6 min walking test (efficacy) | 6 min walking test (meters and number of stops are reported) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 m test (efficacy) | Time to walk 10 m (no stops are allowed) | 90 days | 
| Borg Scale (efficacy) | Borg Scale punctuation after 6 min waking test. Range 0-10. | 90 days | 
| Motor Score (efficacy) | Motor Score (ISNCSCI). Range 0-20 (higher values less severe) | 90 days | 
| Fatigue Severity Scale (FSS) (Efficacy) | FSS puntuación. Range 0-7 (higher values more severe) | 90 days | 
| Patient global impression of changes (PGIC) (efficacy) | PGIG score. Range 1-7 (higher values indicate worsening) | 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). | 90 days | 
| Health state visual analogically scale (efficacy) | Range 0-100 mm (higher values indicate higher health state ) | 90 days | 
| Spinal Cord Independence Measures, SCIM (efficacy) | Range 0-100 (higher values indicate higher independence ) | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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walking abilities, Rimonabant, Endurance, Incomplete SCI