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

Sponsor
Hospital Nacional de Parapléjicos de Toledo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05398913
Collaborator
(none)
12
Enrollment
1
Location
3
Arms
13.6
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized crossover study with three armsRandomized 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
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Adverse events (safety) [150 days]

    number of AE

  2. 6 min walking test (efficacy) [5 days]

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

  3. Biochemical and urine analysis (safety) [8 days]

    Number of participants with clinically significant abnormal laboratory tests results

  4. ECG (safety) [8 days]

    Number of participants with clinically significant abnormal ECG readings

  5. Beck Depression Inventory (BDI) (safety) [15 days]

    Range 0-63 (higher values more severe)

  6. Hospital Anxiety and Depression Scale (HAD) (safety) [15 days]

    Range 0-21(higher values more severe)

  7. Modified Ashworth Scale (safety) [15 days]

    Range 0-4 (higher values more severe)

  8. Penn Scale (safety) [15 days]

    Range 0-4 (higher values more severe)

Secondary Outcome Measures

  1. 10 m test (efficacy) [5 days and 15 days]

    Time to walk 10 m (no stops are allowed)

  2. 6 min walking test (efficacy) [15 days]

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

  3. Borg Scale (efficacy) [5 days and 15 days]

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

  4. WISCI II (efficacy) [5 and 15 days]

    Range 0-20 (higher values less severe)

  5. Motor Score (efficacy) [8 days]

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

  6. Fatigue Severity Scale (FSS) (Efficacy) [5 and 15 days]

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

  7. European Quality of Life -5 Dimensions (EQ-5D) (efficacy) [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) [5 and 15 days]

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

  9. Pain numeric rating scale [8 days]

    Range 0-10 (higher values more severe)

  10. Health state visual analogically scale [8 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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, Principal Investigator, Hospital Nacional de Parapléjicos de Toledo
ClinicalTrials.gov Identifier:
NCT05398913
Other Study ID Numbers:
  • FHNP-CT002
First Posted:
Jun 1, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
May 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, Principal Investigator, Hospital Nacional de Parapléjicos de Toledo
Spinal cord injury
Walking endurance
Incomplete SCI
Traumatic
Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Rimonabant

Study Results

No Results Posted as of Jun 3, 2022