NCT05622994

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 14, 2022

Last Update Submit

November 14, 2022

Conditions

Spinal Cord Injuries

Keywords

walking abilitiesRimonabantEnduranceIncomplete SCI

Outcome Measures

Primary Outcomes (9)

  • Adverse Events (Safety)

    Number of AE

    120 days

  • Biochemical and urine analysis (safety)

    Number of participants with clinically significant abnormal laboratory tests results

    120 days

  • ECG (safety)

    Number of participants with clinically significant abnormal ECG readings

    120 days

  • Hospital Anxiety and Depression Scale (HAD) (safety

    Range 0-21(higher values more severe)

    120 days

  • Modified Ashworth Scale (safety)

    Range 0-4 (higher values more severe)

    90 days

  • Penn Scale (safety)

    Range 0-4 (higher values more severe)

    90 days

  • Pain numeric rating scale (safety)

    Range 0-10 (higher values more severe)

    90 days

  • Questionnaire of falls (safety)

    Number of falls

    120 days

  • 6 min walking test (efficacy)

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

    90 days

Secondary Outcomes (8)

  • 10 m test (efficacy)

    90 days

  • Borg Scale (efficacy)

    90 days

  • Motor Score (efficacy)

    90 days

  • Fatigue Severity Scale (FSS) (Efficacy)

    90 days

  • Patient global impression of changes (PGIC) (efficacy)

    90 days

  • +3 more secondary outcomes

Study Arms (2)

Rimonabant

ACTIVE COMPARATOR

Rimonabant 5mg

Drug: Rimonabant

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Rimonabant

Interventions

RimonabantDRUG

Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.

Also known as: Placebo
PlaceboRimonabant

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nacional de Paraplejicos

Toledo, 45004, Spain

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Officials

  • Antonio Oliviero, MD, PhD

    Hospital Nacional de Parapléjicos

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Oliviero, MD, PhD

CONTACT

+34925247700antonioo@sescam.jccm.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Placebo controlled
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Placebo controlled parallel design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Antonio Oliviero

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 21, 2022

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)