Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— RIMOFATSCI-1  

Official title:

Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury: a Proof-of-concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05398913
• Other study ID #: FHNP-CT002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 12, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: November 2022
• Source: Hospital Nacional de Parapléjicos de Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• Rimonabant
Rimonabant

Locations

Country	Name	City	State
Spain	Hospital Nacional de Paraplejicos	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nacional de Parapléjicos de Toledo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (safety)	number of AE	150 days
Primary	6 min walking test (efficacy)	6 min walking test (meters and number of stops are reported)	5 days
Primary	Biochemical and urine analysis (safety)	Number of participants with clinically significant abnormal laboratory tests results	8 days
Primary	ECG (safety)	Number of participants with clinically significant abnormal ECG readings	8 days
Primary	Beck Depression Inventory (BDI) (safety)	Range 0-63 (higher values more severe)	15 days
Primary	Hospital Anxiety and Depression Scale (HAD) (safety)	Range 0-21(higher values more severe)	15 days
Primary	Modified Ashworth Scale (safety)	Range 0-4 (higher values more severe)	15 days
Primary	Penn Scale (safety)	Range 0-4 (higher values more severe)	15 days
Secondary	10 m test (efficacy)	Time to walk 10 m (no stops are allowed)	5 days and 15 days
Secondary	6 min walking test (efficacy)	6 min walking test (meters and number of stops are reported)	15 days
Secondary	Borg Scale (efficacy)	Borg Scale punctuation after 6 min waking test. Range 0-10.	5 days and 15 days
Secondary	WISCI II (efficacy)	Range 0-20 (higher values less severe)	5 and 15 days
Secondary	Motor Score (efficacy)	Motor Score (ISNCSCI). Range 0-20 (higher values less severe)	8 days
Secondary	Fatigue Severity Scale (FSS) (Efficacy)	FSS puntuación. Range 0-7 (higher values more severe)	5 and 15 days
Secondary	European Quality of Life -5 Dimensions (EQ-5D) (efficacy)	EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 3 problem levels corresponding to patient response choices (higher values worst). A quality-of-life score is obtained according to the answers to the questionnaires (algorithm to calculate the score in euroqol.org). The maximum score is 1 that indicates excellent quality of life (range for Spanish version 0.5-1).	8 days
Secondary	Patient global impression of changes (PGIC) (efficacy)	PGIG score. Range 1-7 (higher values indicate worsening)	5 and 15 days
Secondary	Pain numeric rating scale	Range 0-10 (higher values more severe)	8 days
Secondary	Health state visual analogically scale	Range 0-100 mm (higher values indicate higher health state )	8 days