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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Two pills of placebo will be administered for 5 consecutive days, once per day. |
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| Rimonabant 2.5 mg | Active Comparator | One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. |
|
| Rimonabant 5 mg | Active Comparator | Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimonabant | Drug | Rimonabant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (safety) | number of AE | 150 days |
| 6 min walking test (efficacy) | 6 min walking test (meters and number of stops are reported) | 5 days |
| Biochemical and urine analysis (safety) | Number of participants with clinically significant abnormal laboratory tests results | 8 days |
| ECG (safety) | Number of participants with clinically significant abnormal ECG readings | 8 days |
| Beck Depression Inventory (BDI) (safety) | Range 0-63 (higher values more severe) | 15 days |
| Hospital Anxiety and Depression Scale (HAD) (safety) | Range 0-21(higher values more severe) | 15 days |
| Modified Ashworth Scale (safety) | Range 0-4 (higher values more severe) | 15 days |
| Penn Scale (safety) | Range 0-4 (higher values more severe) | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| 10 m test (efficacy) | Time to walk 10 m (no stops are allowed) | 5 days and 15 days |
| 6 min walking test (efficacy) | 6 min walking test (meters and number of stops are reported) |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
Upon reasonable request
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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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Randomized crossover study with three arms
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| 15 days |
| Borg Scale (efficacy) | Borg Scale punctuation after 6 min waking test. Range 0-10. | 5 days and 15 days |
| WISCI II (efficacy) | Range 0-20 (higher values less severe) | 5 and 15 days |
| Motor Score (efficacy) | Motor Score (ISNCSCI). Range 0-20 (higher values less severe) | 8 days |
| Fatigue Severity Scale (FSS) (Efficacy) | FSS puntuación. Range 0-7 (higher values more severe) | 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). | 8 days |
| Patient global impression of changes (PGIC) (efficacy) | PGIG score. Range 1-7 (higher values indicate worsening) | 5 and 15 days |
| Pain numeric rating scale | Range 0-10 (higher values more severe) | 8 days |
| Health state visual analogically scale | Range 0-100 mm (higher values indicate higher health state ) | 8 days |
| D014947 | Wounds and Injuries |
| D010880 |
| Piperidines |