Clinical trial NCT05622994: Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Official title: Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injuries
Keywords: walking abilities
Rimonabant
Endurance
Incomplete SCI
Lead sponsor: Hospital Nacional de Parapléjicos de Toledo
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled parallel design
Primary purpose: TREATMENT

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events (Safety)
timeFrame: 120 days
measure: Biochemical and urine analysis (safety)
timeFrame: 120 days
measure: ECG (safety)
timeFrame: 120 days
measure: Hospital Anxiety and Depression Scale (HAD) (safety
timeFrame: 120 days
measure: Modified Ashworth Scale (safety)
timeFrame: 90 days
measure: Penn Scale (safety)
timeFrame: 90 days
measure: Pain numeric rating scale (safety)
timeFrame: 90 days
measure: Questionnaire of falls (safety)
timeFrame: 120 days
measure: 6 min walking test (efficacy)
timeFrame: 90 days
Secondary outcomes:
measure: 10 m test (efficacy)
timeFrame: 90 days
measure: Borg Scale (efficacy)
timeFrame: 90 days
measure: Motor Score (efficacy)
timeFrame: 90 days
measure: Fatigue Severity Scale (FSS) (Efficacy)
timeFrame: 90 days
measure: Patient global impression of changes (PGIC) (efficacy)
timeFrame: 90 days
measure: European Quality of Life -5 Dimensions (EQ-5D) (efficacy)
timeFrame: 90 days
measure: Health state visual analogically scale (efficacy)
timeFrame: 90 days
measure: Spinal Cord Independence Measures, SCIM (efficacy)
timeFrame: 90 days
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Hospital Nacional de Paraplejicos
Study officials:
affiliation: Hospital Nacional de Parapléjicos
name: Antonio Oliviero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: