Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
- Registration Number
- NCT05398913
- Lead Sponsor
- Hospital Nacional de Parapléjicos de Toledo
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Rimonabant Two pills of placebo will be administered for 5 consecutive days, once per day. Rimonabant 5 mg Rimonabant Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day. Rimonabant 2.5 mg Rimonabant One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
- Primary Outcome Measures
Name Time Method 6 min walking test (efficacy) 5 days 6 min walking test (meters and number of stops are reported)
ECG (safety) 8 days Number of participants with clinically significant abnormal ECG readings
Modified Ashworth Scale (safety) 15 days Range 0-4 (higher values more severe)
Adverse events (safety) 150 days number of AE
Biochemical and urine analysis (safety) 8 days Number of participants with clinically significant abnormal laboratory tests results
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)
Penn Scale (safety) 15 days Range 0-4 (higher values more severe)
- Secondary Outcome Measures
Name Time Method Patient global impression of changes (PGIC) (efficacy) 5 and 15 days PGIG score. Range 1-7 (higher values indicate worsening)
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).
Pain numeric rating scale 8 days Range 0-10 (higher values more severe)
6 min walking test (efficacy) 15 days 6 min walking test (meters and number of stops are reported)
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)
Health state visual analogically scale 8 days Range 0-100 mm (higher values indicate higher health state )
10 m test (efficacy) 5 days and 15 days Time to walk 10 m (no stops are allowed)
Borg Scale (efficacy) 5 days and 15 days Borg Scale punctuation after 6 min waking test. Range 0-10.
Trial Locations
- Locations (1)
Hospital Nacional de Paraplejicos
🇪🇸Toledo, Spain