RIMOFATSCI-2: Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Rimonabant Rimonabant 5mg |
Drug: Rimonabant
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
Other Names:
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Placebo Comparator: Placebo Placebo |
Drug: Rimonabant
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 6 min walking test (efficacy) [90 days]
6 min walking test (meters and number of stops are reported)
Secondary Outcome Measures
- 10 m test (efficacy) [90 days]
Time to walk 10 m (no stops are allowed)
- 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 )
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age >18 yo and <75yo
-
Non progressive spinal cord injury
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Incomplete lesion (AIS C or D)
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Neurological level between C4 and L1
-
Chronic stage (>1 year since injury)
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Preserved walking ability for at least 5 m (aid allowed)
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Capability to provide informed consent
-
For fertile women, possibility to use anti conceptive methods
Exclusion Criteria:
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Age <18 yo or >75
-
AIS A, B or E
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Neurological level above C4 or below L1
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Subacute stage (<1 year since injury)
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Preserved walking ability for less than 5 m (aid allowed)
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Pregnancy or breast feeding
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For fertile women, impossibility to use anti conceptive methods
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anticoagulant treatment
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Hypothyroidism
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Severe bone, kidney or liver disfunction
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Impossibility to reach the hospital
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Impossibility to rovide informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital Nacional de Paraplejicos | Toledo | Spain | 45004 |
Sponsors and Collaborators
- Hospital Nacional de Parapléjicos de Toledo
Investigators
- Principal Investigator: Antonio Oliviero, MD, PhD, Hospital Nacional de Parapléjicos
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FHNP-CT003