Spinal Cord Injuries
Conditions
Keywords
walking abilities, Rimonabant, Endurance, Incomplete SCI
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).
Interventions
DRUGRimonabant
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
Sponsors
Hospital Nacional de Parapléjicos de Toledo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo controlled
Intervention model description
Placebo controlled parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 min walking test (efficacy) | 90 days | 6 min walking test (meters and number of stops are reported) |
| Adverse Events (Safety) | 120 days | Number of AE |
| Biochemical and urine analysis (safety) | 120 days | Number of participants with clinically significant abnormal laboratory tests results |
| ECG (safety) | 120 days | Number of participants with clinically significant abnormal ECG readings |
| Hospital Anxiety and Depression Scale (HAD) (safety | 120 days | Range 0-21(higher values more severe) |
| 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) |
| Pain numeric rating scale (safety) | 90 days | Range 0-10 (higher values more severe) |
| Questionnaire of falls (safety) | 120 days | Number of falls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Fatigue Severity Scale (FSS) (Efficacy) | 90 days | FSS puntuación. Range 0-7 (higher values more severe) |
| Patient global impression of changes (PGIC) (efficacy) | 90 days | PGIG score. Range 1-7 (higher values indicate worsening) |
| 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). |
| Health state visual analogically scale (efficacy) | 90 days | Range 0-100 mm (higher values indicate higher health state ) |
| Spinal Cord Independence Measures, SCIM (efficacy) | 90 days | Range 0-100 (higher values indicate higher independence ) |
| 10 m test (efficacy) | 90 days | Time to walk 10 m (no stops are allowed) |
Countries
Spain
Contacts
Primary ContactAntonio Oliviero, MD, PhD
Outcome results
None listed