Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury (RIMOFATSCI-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Drug: Rimonabant

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).

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45004
    • Hospital Nacional de Parapléjicos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Two pills of placebo will be administered for 5 consecutive days, once per day.	Drug: Rimonabant; Rimonabant
ACTIVE_COMPARATOR: 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.	Drug: Rimonabant; Rimonabant
ACTIVE_COMPARATOR: Rimonabant 5 mg; Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.	Drug: Rimonabant; Rimonabant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (safety)	number of AE	150 days
6 min walking test (efficacy)	6 min walking test (meters and number of stops are reported)	5 days
Biochemical and urine analysis (safety)	Number of participants with clinically significant abnormal laboratory tests results	8 days
ECG (safety)	Number of participants with clinically significant abnormal ECG readings	8 days
Beck Depression Inventory (BDI) (safety)	Range 0-63 (higher values more severe)	15 days
Hospital Anxiety and Depression Scale (HAD) (safety)	Range 0-21(higher values more severe)	15 days
Modified Ashworth Scale (safety)	Range 0-4 (higher values more severe)	15 days
Penn Scale (safety)	Range 0-4 (higher values more severe)	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 m test (efficacy)	Time to walk 10 m (no stops are allowed)	5 days and 15 days
6 min walking test (efficacy)	6 min walking test (meters and number of stops are reported)	15 days
Borg Scale (efficacy)	Borg Scale punctuation after 6 min waking test. Range 0-10.	5 days and 15 days
WISCI II (efficacy)	Range 0-20 (higher values less severe)	5 and 15 days
Motor Score (efficacy)	Motor Score (ISNCSCI). Range 0-20 (higher values less severe)	8 days
Fatigue Severity Scale (FSS) (Efficacy)	FSS puntuación. Range 0-7 (higher values more severe)	5 and 15 days
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
Patient global impression of changes (PGIC) (efficacy)	PGIG score. Range 1-7 (higher values indicate worsening)	5 and 15 days
Pain numeric rating scale	Range 0-10 (higher values more severe)	8 days
Health state visual analogically scale	Range 0-100 mm (higher values indicate higher health state )	8 days

Collaborators and Investigators

• Sponsor: Hospital Nacional de Parapléjicos de Toledo

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2021
• Primary Completion (ACTUAL): June 7, 2022
• Study Completion (ACTUAL): June 7, 2022

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (ACTUAL): June 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Spinal cord injury; Traumatic; Incomplete SCI; Walking endurance
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Cannabinoid Receptor Modulators; Cannabinoid Receptor Antagonists; Rimonabant
• Other Study ID Numbers: FHNP-CT002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No