Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
NCT ID: NCT05398913
Last Updated: 2022-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
8 participants
INTERVENTIONAL
2021-05-12
2022-06-07
Brief Summary
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Detailed Description
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Main goal is to test safety of Rimonabant in a specific population (incomplete spinal cord injury).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Two pills of placebo will be administered for 5 consecutive days, once per day.
Rimonabant
Rimonabant
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.
Rimonabant
Rimonabant
Rimonabant 5 mg
Two pills of Rimonabant 2.5mg will be administered for 5 consecutive days, once per day.
Rimonabant
Rimonabant
Interventions
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Rimonabant
Rimonabant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hospital Nacional de Parapléjicos de Toledo
OTHER
Responsible Party
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Antonio Oliviero
Principal Investigator
Principal Investigators
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Antonio Oliviero, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Nacional de Parapléjicos
Locations
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Hospital Nacional de Paraplejicos
Toledo, , Spain
Countries
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Other Identifiers
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FHNP-CT002
Identifier Type: -
Identifier Source: org_study_id
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