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

Sponsor
Hospital Nacional de Parapléjicos de Toledo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05622994
Collaborator
(none)
80
1
2
12
6.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Placebo controlled parallel designPlacebo controlled parallel design
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Placebo controlled
Primary Purpose:
Treatment
Official Title:
Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
  • Placebo Comparator: Placebo

    Placebo

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

    Primary Outcome Measures

    1. Adverse Events (Safety) [120 days]

      Number of AE

    2. Biochemical and urine analysis (safety) [120 days]

      Number of participants with clinically significant abnormal laboratory tests results

    3. ECG (safety) [120 days]

      Number of participants with clinically significant abnormal ECG readings

    4. Hospital Anxiety and Depression Scale (HAD) (safety [120 days]

      Range 0-21(higher values more severe)

    5. Modified Ashworth Scale (safety) [90 days]

      Range 0-4 (higher values more severe)

    6. Penn Scale (safety) [90 days]

      Range 0-4 (higher values more severe)

    7. Pain numeric rating scale (safety) [90 days]

      Range 0-10 (higher values more severe)

    8. Questionnaire of falls (safety) [120 days]

      Number of falls

    9. 6 min walking test (efficacy) [90 days]

      6 min walking test (meters and number of stops are reported)

    Secondary Outcome Measures

    1. 10 m test (efficacy) [90 days]

      Time to walk 10 m (no stops are allowed)

    2. Borg Scale (efficacy) [90 days]

      Borg Scale punctuation after 6 min waking test. Range 0-10.

    3. Motor Score (efficacy) [90 days]

      Motor Score (ISNCSCI). Range 0-20 (higher values less severe)

    4. Fatigue Severity Scale (FSS) (Efficacy) [90 days]

      FSS puntuación. Range 0-7 (higher values more severe)

    5. Patient global impression of changes (PGIC) (efficacy) [90 days]

      PGIG score. Range 1-7 (higher values indicate worsening)

    6. European Quality of Life -5 Dimensions (EQ-5D) (efficacy) [90 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).

    7. Health state visual analogically scale (efficacy) [90 days]

      Range 0-100 mm (higher values indicate higher health state )

    8. Spinal Cord Independence Measures, SCIM (efficacy) [90 days]

      Range 0-100 (higher values indicate higher independence )

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Nacional de Paraplejicos Toledo Spain 45004

    Sponsors and Collaborators

    • Hospital Nacional de Parapléjicos de Toledo

    Investigators

    • Principal Investigator: Antonio Oliviero, MD, PhD, Hospital Nacional de Parapléjicos

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antonio Oliviero, Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo
    ClinicalTrials.gov Identifier:
    NCT05622994
    Other Study ID Numbers:
    • FHNP-CT003
    First Posted:
    Nov 21, 2022
    Last Update Posted:
    Nov 21, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Antonio Oliviero, Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 21, 2022