RecruitingPhase 4NCT05302999
Feasibility of Early Gabapentin as an Intervention for Neurorecovery
Sponsor
MetroHealth Medical Center
Enrollment
42 participants
Start Date
Mar 14, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- Traumatic SCI;
- All levels of SCI;
- All severities of SCI, AIS A-D;
- Age 18 years and older.
- Agree to participate and start study drug within 120 hours' post-injury.
- Adequate cognition and communication to provide informed consent
Exclusion Criteria2
- Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) < 13 at 120 hours' post-injury.
- Documented use of gabapentinoids at the time of injury.
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Interventions
DRUGGabapentin
Generic gabapentin
DRUGPlacebo
Inert cellulose
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05302999
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