Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
NCT ID: NCT05622994
Last Updated: 2022-11-21
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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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2022-11-30
2023-11-30
Brief Summary
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Detailed Description
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Main goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) of Rimonabant in a specific population (incomplete spinal cord injury).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rimonabant
Rimonabant 5mg
Rimonabant
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
Placebo
Placebo
Rimonabant
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
Interventions
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Rimonabant
Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non progressive spinal cord injury
* Incomplete lesion (AIS C or D)
* Neurological level between C4 and L1
* Chronic stage (\>1 year since injury)
* Preserved walking ability for at least 5 m (aid allowed)
* Capability to provide informed consent
* For fertile women, possibility to use anti conceptive methods
Exclusion Criteria
* AIS A, B 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 bone, kidney or liver disfunction
* Impossibility to reach the hospital
* Impossibility to rovide informed consent
18 Years
75 Years
ALL
No
Sponsors
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Hospital Nacional de Parapléjicos de Toledo
OTHER
Responsible Party
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Antonio Oliviero
Antonio Oliviero
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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Central Contacts
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Other Identifiers
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FHNP-CT003
Identifier Type: -
Identifier Source: org_study_id
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