Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

NCT ID: NCT05622994

Last Updated: 2022-11-21

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period.

Main goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) 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

PARALLEL

Placebo controlled parallel design
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Placebo controlled

Study Groups

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Rimonabant

Rimonabant 5mg

Group Type ACTIVE_COMPARATOR

Rimonabant

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Rimonabant

Intervention Type DRUG

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

Interventions

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Rimonabant

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

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Antonio Oliviero

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

Central Contacts

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Antonio Oliviero, MD, PhD

Role: CONTACT

+34925247700 ext. 47120

Other Identifiers

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FHNP-CT003

Identifier Type: -

Identifier Source: org_study_id

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