Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury (RIMOFATSCI-2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Drug: Rimonabant

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Antonio Oliviero, MD, PhD; Phone Number: 47120 +34925247700; Email: antonioo@sescam.jccm.es

Study Locations

• Spain
  • Toledo, Spain, 45004
    • Hospital Nacional de Parapléjicos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Rimonabant; Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.; Other Names: Placebo
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: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (Safety)	Number of AE	120 days
Biochemical and urine analysis (safety)	Number of participants with clinically significant abnormal laboratory tests results	120 days
ECG (safety)	Number of participants with clinically significant abnormal ECG readings	120 days
Hospital Anxiety and Depression Scale (HAD) (safety	Range 0-21(higher values more severe)	120 days
Modified Ashworth Scale (safety)	Range 0-4 (higher values more severe)	90 days
Penn Scale (safety)	Range 0-4 (higher values more severe)	90 days
Pain numeric rating scale (safety)	Range 0-10 (higher values more severe)	90 days
Questionnaire of falls (safety)	Number of falls	120 days
6 min walking test (efficacy)	6 min walking test (meters and number of stops are reported)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 m test (efficacy)	Time to walk 10 m (no stops are allowed)	90 days
Borg Scale (efficacy)	Borg Scale punctuation after 6 min waking test. Range 0-10.	90 days
Motor Score (efficacy)	Motor Score (ISNCSCI). Range 0-20 (higher values less severe)	90 days
Fatigue Severity Scale (FSS) (Efficacy)	FSS puntuación. Range 0-7 (higher values more severe)	90 days
Patient global impression of changes (PGIC) (efficacy)	PGIG score. Range 1-7 (higher values indicate worsening)	90 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).	90 days
Health state visual analogically scale (efficacy)	Range 0-100 mm (higher values indicate higher health state )	90 days
Spinal Cord Independence Measures, SCIM (efficacy)	Range 0-100 (higher values indicate higher independence )	90 days

Collaborators and Investigators

• Sponsor: Hospital Nacional de Parapléjicos de Toledo

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Endurance; Incomplete SCI; walking abilities; Rimonabant
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Cannabinoid Receptor Modulators; Cannabinoid Receptor Antagonists; Rimonabant
• Other Study ID Numbers: FHNP-CT003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No