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

Primary Purpose

Spinal Cord Injuries

Status
Not yet recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Rimonabant
Sponsored by
Hospital Nacional de Parapléjicos de Toledo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring walking abilities, Rimonabant, Endurance, Incomplete SCI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Nacional de Paraplejicos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rimonabant

Placebo

Arm Description

Rimonabant 5mg

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2022
Last Updated
November 14, 2022
Sponsor
Hospital Nacional de Parapléjicos de Toledo
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1. Study Identification

Unique Protocol Identification Number
NCT05622994
Brief Title
Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Acronym
RIMOFATSCI-2
Official Title
Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Nacional de Parapléjicos de Toledo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
walking abilities, Rimonabant, Endurance, Incomplete SCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo controlled parallel design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo controlled
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rimonabant
Arm Type
Active Comparator
Arm Description
Rimonabant 5mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rimonabant
Other Intervention Name(s)
Placebo
Intervention Description
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
Primary Outcome Measure Information:
Title
Adverse Events (Safety)
Description
Number of AE
Time Frame
120 days
Title
Biochemical and urine analysis (safety)
Description
Number of participants with clinically significant abnormal laboratory tests results
Time Frame
120 days
Title
ECG (safety)
Description
Number of participants with clinically significant abnormal ECG readings
Time Frame
120 days
Title
Hospital Anxiety and Depression Scale (HAD) (safety
Description
Range 0-21(higher values more severe)
Time Frame
120 days
Title
Modified Ashworth Scale (safety)
Description
Range 0-4 (higher values more severe)
Time Frame
90 days
Title
Penn Scale (safety)
Description
Range 0-4 (higher values more severe)
Time Frame
90 days
Title
Pain numeric rating scale (safety)
Description
Range 0-10 (higher values more severe)
Time Frame
90 days
Title
Questionnaire of falls (safety)
Description
Number of falls
Time Frame
120 days
Title
6 min walking test (efficacy)
Description
6 min walking test (meters and number of stops are reported)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
10 m test (efficacy)
Description
Time to walk 10 m (no stops are allowed)
Time Frame
90 days
Title
Borg Scale (efficacy)
Description
Borg Scale punctuation after 6 min waking test. Range 0-10.
Time Frame
90 days
Title
Motor Score (efficacy)
Description
Motor Score (ISNCSCI). Range 0-20 (higher values less severe)
Time Frame
90 days
Title
Fatigue Severity Scale (FSS) (Efficacy)
Description
FSS puntuación. Range 0-7 (higher values more severe)
Time Frame
90 days
Title
Patient global impression of changes (PGIC) (efficacy)
Description
PGIG score. Range 1-7 (higher values indicate worsening)
Time Frame
90 days
Title
European Quality of Life -5 Dimensions (EQ-5D) (efficacy)
Description
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).
Time Frame
90 days
Title
Health state visual analogically scale (efficacy)
Description
Range 0-100 mm (higher values indicate higher health state )
Time Frame
90 days
Title
Spinal Cord Independence Measures, SCIM (efficacy)
Description
Range 0-100 (higher values indicate higher independence )
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Oliviero, MD, PhD
Phone
+34925247700
Ext
47120
Email
antonioo@sescam.jccm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Oliviero, MD, PhD
Organizational Affiliation
Hospital Nacional de Parapléjicos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nacional de Paraplejicos
City
Toledo
ZIP/Postal Code
45004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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