Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Main goal is to test safety of Rimonabant in a specific population (incomplete spinal cord injury).

Official Title
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Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study

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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Interventional Model Description: Randomized crossover study with three arms
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Two pills of placebo will be administered for 5 consecutive days, once per day. | Drug: Rimonabant<br>* Rimonabant<br>|
| Active Comparator: Rimonabant 2.5 mg<br>One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. | Drug: Rimonabant<br>* Rimonabant<br>|
| Active Comparator: Rimonabant 5 mg<br>Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. | Drug: Rimonabant<br>* Rimonabant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, Walking endurance, Incomplete SCI, Traumatic