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

Hospital Nacional de Parapléjicos de Toledo

Status and phase: Completed; Phase 2; Phase 1

Conditions: Spinal Cord Injuries

Treatments: Drug: Rimonabant

Study type: Interventional

Funder types: Other

Identifiers

NCT05398913

FHNP-CT002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Rimonabant

Rimonabant 2.5 mg

Active Comparator group

Description:

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

Treatment:

Drug: Rimonabant

Rimonabant 5 mg

Active Comparator group

Description:

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

Treatment:

Drug: Rimonabant