Spinal Cord Injuries
Conditions
Keywords
Spinal cord injury, Walking endurance, Incomplete SCI, Traumatic
Brief summary
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.
Detailed description
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).
Interventions
DRUGRimonabant
Rimonabant
Sponsors
Hospital Nacional de Parapléjicos de Toledo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized crossover study with three arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Traumatic spinal cord injury * Incomplete lesion (AIS D) * Neurological level between C4 and L1 * Chronic stage (\>1 year since injury) * Preserved walking ability for at least 5 m (aid allowed) * Psychiatric assessment to exclude individuals with high suicide risk * Capability to provide informed consent * For fertile women, possibility to use anti conceptive methods
Exclusion criteria
* Non traumatic spinal cord injury * AIS A, B, C 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 kidney or liver dysfunction * Severe depression * Fatigue treatment in the last 6 months * Impossibility to reach the Hospital * Impossibility to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (safety) | 150 days | number of AE |
| 6 min walking test (efficacy) | 5 days | 6 min walking test (meters and number of stops are reported) |
| Biochemical and urine analysis (safety) | 8 days | Number of participants with clinically significant abnormal laboratory tests results |
| ECG (safety) | 8 days | Number of participants with clinically significant abnormal ECG readings |
| Beck Depression Inventory (BDI) (safety) | 15 days | Range 0-63 (higher values more severe) |
| Hospital Anxiety and Depression Scale (HAD) (safety) | 15 days | Range 0-21(higher values more severe) |
| Modified Ashworth Scale (safety) | 15 days | Range 0-4 (higher values more severe) |
| Penn Scale (safety) | 15 days | Range 0-4 (higher values more severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain numeric rating scale | 8 days | Range 0-10 (higher values more severe) |
| 10 m test (efficacy) | 5 days and 15 days | Time to walk 10 m (no stops are allowed) |
| Health state visual analogically scale | 8 days | Range 0-100 mm (higher values indicate higher health state ) |
| 6 min walking test (efficacy) | 15 days | 6 min walking test (meters and number of stops are reported) |
| Borg Scale (efficacy) | 5 days and 15 days | Borg Scale punctuation after 6 min waking test. Range 0-10. |
| WISCI II (efficacy) | 5 and 15 days | Range 0-20 (higher values less severe) |
| Motor Score (efficacy) | 8 days | Motor Score (ISNCSCI). Range 0-20 (higher values less severe) |
| Fatigue Severity Scale (FSS) (Efficacy) | 5 and 15 days | FSS puntuación. Range 0-7 (higher values more severe) |
| European Quality of Life -5 Dimensions (EQ-5D) (efficacy) | 8 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). |
| Patient global impression of changes (PGIC) (efficacy) | 5 and 15 days | PGIG score. Range 1-7 (higher values indicate worsening) |
Countries
Spain
Outcome results
None listed