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NCT Number: NCT05398913

Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Nacional de Paraplejicos

Toledo, 45004, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rimonabant

Drug

Rimonabant

Primary outcomes

  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 outcomes

  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 )

Sponsors and collaborators

Lead sponsor

Hospital Nacional de Parapléjicos de Toledo

Other

Registry information

Official study title

Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study

Acronym: RIMOFATSCI-1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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