Clinical trial NCT05398913: Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Official title: Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injury
Walking endurance
Incomplete SCI
Traumatic
Lead sponsor: Hospital Nacional de Parapléjicos de Toledo
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover study with three arms
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events (safety)
timeFrame: 150 days
measure: 6 min walking test (efficacy)
timeFrame: 5 days
measure: Biochemical and urine analysis (safety)
timeFrame: 8 days
measure: ECG (safety)
timeFrame: 8 days
measure: Beck Depression Inventory (BDI) (safety)
timeFrame: 15 days
measure: Hospital Anxiety and Depression Scale (HAD) (safety)
timeFrame: 15 days
measure: Modified Ashworth Scale (safety)
timeFrame: 15 days
measure: Penn Scale (safety)
timeFrame: 15 days
Secondary outcomes:
measure: 10 m test (efficacy)
timeFrame: 5 days and 15 days
measure: 6 min walking test (efficacy)
timeFrame: 15 days
measure: Borg Scale (efficacy)
timeFrame: 5 days and 15 days
measure: WISCI II (efficacy)
timeFrame: 5 and 15 days
measure: Motor Score (efficacy)
timeFrame: 8 days
measure: Fatigue Severity Scale (FSS) (Efficacy)
timeFrame: 5 and 15 days
measure: European Quality of Life -5 Dimensions (EQ-5D) (efficacy)
timeFrame: 8 days
measure: Patient global impression of changes (PGIC) (efficacy)
timeFrame: 5 and 15 days
measure: Pain numeric rating scale
timeFrame: 8 days
measure: Health state visual analogically scale
timeFrame: 8 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: