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Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury (RIMOFATSCI-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05398913
Recruitment Status : Completed
First Posted : June 1, 2022
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: Rimonabant Phase 1 Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover study with three arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study
Actual Study Start Date : May 12, 2021
Actual Primary Completion Date : June 7, 2022
Actual Study Completion Date : June 7, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Two pills of placebo will be administered for 5 consecutive days, once per day.
 Drug: Rimonabant
Rimonabant
Active Comparator: Rimonabant 2.5 mg
One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
 Drug: Rimonabant
Rimonabant
Active Comparator: Rimonabant 5 mg
Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
 Drug: Rimonabant
Rimonabant


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events (safety) [ Time Frame: 150 days ]
    number of AE

  2. 6 min walking test (efficacy) [ Time Frame: 5 days ]
    6 min walking test (meters and number of stops are reported)

  3. Biochemical and urine analysis (safety) [ Time Frame: 8 days ]
    Number of participants with clinically significant abnormal laboratory tests results

  4. ECG (safety) [ Time Frame: 8 days ]
    Number of participants with clinically significant abnormal ECG readings

  5. Beck Depression Inventory (BDI) (safety) [ Time Frame: 15 days ]
    Range 0-63 (higher values more severe)

  6. Hospital Anxiety and Depression Scale (HAD) (safety) [ Time Frame: 15 days ]
    Range 0-21(higher values more severe)

  7. Modified Ashworth Scale (safety) [ Time Frame: 15 days ]
    Range 0-4 (higher values more severe)

  8. Penn Scale (safety) [ Time Frame: 15 days ]
    Range 0-4 (higher values more severe)


Secondary Outcome Measures :
  1. 10 m test (efficacy) [ Time Frame: 5 days and 15 days ]
    Time to walk 10 m (no stops are allowed)

  2. 6 min walking test (efficacy) [ Time Frame: 15 days ]
    6 min walking test (meters and number of stops are reported)

  3. Borg Scale (efficacy) [ Time Frame: 5 days and 15 days ]
    Borg Scale punctuation after 6 min waking test. Range 0-10.

  4. WISCI II (efficacy) [ Time Frame: 5 and 15 days ]
    Range 0-20 (higher values less severe)

  5. Motor Score (efficacy) [ Time Frame: 8 days ]
    Motor Score (ISNCSCI). Range 0-20 (higher values less severe)

  6. Fatigue Severity Scale (FSS) (Efficacy) [ Time Frame: 5 and 15 days ]
    FSS puntuación. Range 0-7 (higher values more severe)

  7. European Quality of Life -5 Dimensions (EQ-5D) (efficacy) [ Time Frame: 8 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).

  8. Patient global impression of changes (PGIC) (efficacy) [ Time Frame: 5 and 15 days ]
    PGIG score. Range 1-7 (higher values indicate worsening)

  9. Pain numeric rating scale [ Time Frame: 8 days ]
    Range 0-10 (higher values more severe)

  10. Health state visual analogically scale [ Time Frame: 8 days ]
    Range 0-100 mm (higher values indicate higher health state )


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05398913


Locations
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Spain
Hospital Nacional de Paraplejicos
Toledo, Spain, 45004
Sponsors and Collaborators
Hospital Nacional de Parapléjicos de Toledo
Investigators
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Principal Investigator: Antonio Oliviero, MD, PhD Hospital Nacional de Parapléjicos
More Information
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Responsible Party: Antonio Oliviero, Principal Investigator, Hospital Nacional de Parapléjicos de Toledo
ClinicalTrials.gov Identifier: NCT05398913    
Other Study ID Numbers: FHNP-CT002
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Upon reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo:
Spinal cord injury
Walking endurance
Incomplete SCI
Traumatic
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Rimonabant
Anti-Obesity Agents
 Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs