Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

NCT05398913 | Completed Phase 1 DMC

• 1 other identifier: FHNP-CT002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injury; Walking endurance; Incomplete SCI; Traumatic

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (10)

• 10 m test (efficacy)

  5 days and 15 days

• 6 min walking test (efficacy)

  15 days

• Borg Scale (efficacy)

  5 days and 15 days

• WISCI II (efficacy)

  5 and 15 days

• Motor Score (efficacy)

  8 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Two pills of placebo will be administered for 5 consecutive days, once per day.

Drug: Rimonabant

Rimonabant 2.5 mg

ACTIVE COMPARATOR

One pill of placebo and one pill of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.

Drug: Rimonabant

Rimonabant 5 mg

ACTIVE COMPARATOR

Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.

Drug: Rimonabant

Interventions

Rimonabant DRUG

Rimonabant

Placebo; Rimonabant 2.5 mg; Rimonabant 5 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Nacional de Parapléjicos de Toledo: lead

Study Sites (1)

Hospital Nacional de Paraplejicos

Toledo, 45004, Spain

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Antonio Oliviero, MD, PhD

  Hospital Nacional de Parapléjicos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized crossover study with three arms

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 1, 2022
• Study Start: May 12, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)