Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury (RIMOFATSCI-1)
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Rimonabant
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal cord injury, Walking endurance, Incomplete SCI, Traumatic
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hospital Nacional de Paraplejicos
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Rimonabant 2.5 mg
Rimonabant 5 mg
Arm Description
Two pills of placebo will be administered for 5 consecutive days, once per day.
One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
Outcomes
Primary Outcome Measures
Adverse events (safety)
number of AE
6 min walking test (efficacy)
6 min walking test (meters and number of stops are reported)
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
Beck Depression Inventory (BDI) (safety)
Range 0-63 (higher values more severe)
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)
Secondary Outcome Measures
10 m test (efficacy)
Time to walk 10 m (no stops are allowed)
6 min walking test (efficacy)
6 min walking test (meters and number of stops are reported)
Borg Scale (efficacy)
Borg Scale punctuation after 6 min waking test. Range 0-10.
WISCI II (efficacy)
Range 0-20 (higher values less severe)
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)
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).
Patient global impression of changes (PGIC) (efficacy)
PGIG score. Range 1-7 (higher values indicate worsening)
Pain numeric rating scale
Range 0-10 (higher values more severe)
Health state visual analogically scale
Range 0-100 mm (higher values indicate higher health state )
Full Information
NCT ID
NCT05398913
First Posted
May 23, 2022
Last Updated
November 13, 2022
Sponsor
Hospital Nacional de Parapléjicos de Toledo
1. Study Identification
Unique Protocol Identification Number
NCT05398913
Brief Title
Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Acronym
RIMOFATSCI-1
Official Title
Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal cord injury, Walking endurance, Incomplete SCI, Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover study with three arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two pills of placebo will be administered for 5 consecutive days, once per day.
Arm Title
Rimonabant 2.5 mg
Arm Type
Active Comparator
Arm Description
One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
Arm Title
Rimonabant 5 mg
Arm Type
Active Comparator
Arm Description
Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
Intervention Type
Drug
Intervention Name(s)
Rimonabant
Intervention Description
Rimonabant
Primary Outcome Measure Information:
Title
Adverse events (safety)
Description
number of AE
Time Frame
150 days
Title
6 min walking test (efficacy)
Description
6 min walking test (meters and number of stops are reported)
Time Frame
5 days
Title
Biochemical and urine analysis (safety)
Description
Number of participants with clinically significant abnormal laboratory tests results
Time Frame
8 days
Title
ECG (safety)
Description
Number of participants with clinically significant abnormal ECG readings
Time Frame
8 days
Title
Beck Depression Inventory (BDI) (safety)
Description
Range 0-63 (higher values more severe)
Time Frame
15 days
Title
Hospital Anxiety and Depression Scale (HAD) (safety)
Description
Range 0-21(higher values more severe)
Time Frame
15 days
Title
Modified Ashworth Scale (safety)
Description
Range 0-4 (higher values more severe)
Time Frame
15 days
Title
Penn Scale (safety)
Description
Range 0-4 (higher values more severe)
Time Frame
15 days
Secondary Outcome Measure Information:
Title
10 m test (efficacy)
Description
Time to walk 10 m (no stops are allowed)
Time Frame
5 days and 15 days
Title
6 min walking test (efficacy)
Description
6 min walking test (meters and number of stops are reported)
Time Frame
15 days
Title
Borg Scale (efficacy)
Description
Borg Scale punctuation after 6 min waking test. Range 0-10.
Time Frame
5 days and 15 days
Title
WISCI II (efficacy)
Description
Range 0-20 (higher values less severe)
Time Frame
5 and 15 days
Title
Motor Score (efficacy)
Description
Motor Score (ISNCSCI). Range 0-20 (higher values less severe)
Time Frame
8 days
Title
Fatigue Severity Scale (FSS) (Efficacy)
Description
FSS puntuación. Range 0-7 (higher values more severe)
Time Frame
5 and 15 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
8 days
Title
Patient global impression of changes (PGIC) (efficacy)
Description
PGIG score. Range 1-7 (higher values indicate worsening)
Time Frame
5 and 15 days
Title
Pain numeric rating scale
Description
Range 0-10 (higher values more severe)
Time Frame
8 days
Title
Health state visual analogically scale
Description
Range 0-100 mm (higher values indicate higher health state )
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
IPD Sharing Plan Description
Upon reasonable request
Learn more about this trial
Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
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