Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

NCT ID: NCT05398913

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2022-06-07

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized crossover study with three arms
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Two pills of placebo will be administered for 5 consecutive days, once per day.

Group Type PLACEBO_COMPARATOR

Rimonabant

Intervention Type DRUG

Rimonabant

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.

Group Type ACTIVE_COMPARATOR

Rimonabant

Intervention Type DRUG

Rimonabant

Rimonabant 5 mg

Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.

Group Type ACTIVE_COMPARATOR

Rimonabant

Intervention Type DRUG

Rimonabant

Interventions

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Rimonabant

Rimonabant

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Nacional de Parapléjicos de Toledo

OTHER

Sponsor Role lead

Responsible Party

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Antonio Oliviero

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Oliviero, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nacional de Parapléjicos

Locations

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Hospital Nacional de Paraplejicos

Toledo, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FHNP-CT002

Identifier Type: -

Identifier Source: org_study_id

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