Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— RIMOFATSCI-2  

Official title:

Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05622994
• Other study ID #: FHNP-CT003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2022
• Est. completion date: November 2023

Study information

• Verified date: November 2022
• Source: Hospital Nacional de Parapléjicos de Toledo
• Contact: Antonio Oliviero, MD, PhD
• Phone: +34925247700
• Email: antonioo[@]sescam.jccm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age >18 yo and <75yo

• Non progressive spinal cord injury

• Incomplete lesion (AIS C or D)

• Neurological level between C4 and L1

• Chronic stage (>1 year since injury)

• Preserved walking ability for at least 5 m (aid allowed)

• Capability to provide informed consent

• For fertile women, possibility to use anti conceptive methods

Exclusion Criteria:

• Age <18 yo or >75

• AIS A, B 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 bone, kidney or liver disfunction

• Impossibility to reach the hospital

• Impossibility to rovide informed consent

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Drug:
• Rimonabant
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.

Locations

Country	Name	City	State
Spain	Hospital Nacional de Paraplejicos	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nacional de Parapléjicos de Toledo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (Safety)	Number of AE	120 days
Primary	Biochemical and urine analysis (safety)	Number of participants with clinically significant abnormal laboratory tests results	120 days
Primary	ECG (safety)	Number of participants with clinically significant abnormal ECG readings	120 days
Primary	Hospital Anxiety and Depression Scale (HAD) (safety	Range 0-21(higher values more severe)	120 days
Primary	Modified Ashworth Scale (safety)	Range 0-4 (higher values more severe)	90 days
Primary	Penn Scale (safety)	Range 0-4 (higher values more severe)	90 days
Primary	Pain numeric rating scale (safety)	Range 0-10 (higher values more severe)	90 days
Primary	Questionnaire of falls (safety)	Number of falls	120 days
Primary	6 min walking test (efficacy)	6 min walking test (meters and number of stops are reported)	90 days
Secondary	10 m test (efficacy)	Time to walk 10 m (no stops are allowed)	90 days
Secondary	Borg Scale (efficacy)	Borg Scale punctuation after 6 min waking test. Range 0-10.	90 days
Secondary	Motor Score (efficacy)	Motor Score (ISNCSCI). Range 0-20 (higher values less severe)	90 days
Secondary	Fatigue Severity Scale (FSS) (Efficacy)	FSS puntuación. Range 0-7 (higher values more severe)	90 days
Secondary	Patient global impression of changes (PGIC) (efficacy)	PGIG score. Range 1-7 (higher values indicate worsening)	90 days
Secondary	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).	90 days
Secondary	Health state visual analogically scale (efficacy)	Range 0-100 mm (higher values indicate higher health state )	90 days
Secondary	Spinal Cord Independence Measures, SCIM (efficacy)	Range 0-100 (higher values indicate higher independence )	90 days