Status:
RECRUITING
Feasibility of Early Gabapentin as an Intervention for Neurorecovery
Lead Sponsor:
MetroHealth Medical Center
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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....
Detailed Description
Gabapentin is a medication commonly used in spinal cord injury (SCI) to manage neuropathic pain. Emerging preclinical and clinical evidence suggests that early initiation of low to medium doses of gab...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05302999
Start Date
March 14 2022
End Date
August 31 2026
Last Update
December 2 2025
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109