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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimonabant | Active Comparator | Rimonabant 5mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimonabant | Drug | Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration. |
|
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Oliviero, MD, PhD | Contact | +34925247700 | 47120 | antonioo@sescam.jccm.es |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Oliviero, MD, PhD | Hospital Nacional de Parapléjicos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional de Paraplejicos | Toledo | 45004 | Spain |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000077285 | Rimonabant |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Placebo controlled parallel design
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Placebo controlled
6 min walking test (meters and number of stops are reported)
| 90 days |
| 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 |
| D014947 | Wounds and Injuries |
| D010880 |
| Piperidines |