Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 gabapentin and continued delivery for a range of 2 weeks to 4 months has a persistent, positive effect on motor and autonomic neurologic recovery. The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the early administration of gabapentin as an intervention for neurorecovery. A mock efficacy design will be employed. Participants will be stratified based on ASIA Impairment Scale (AIS) grade A-B or C-D and randomized to 1 of 3 arms. Study medication will be initiated within 5 days post-injury and administered for 90 days. Participants will be followed for an additional 90 days after stopping treatment. ;

Study Design

Related Conditions & MeSH terms

Spinal Cord Injuries

Clinical Trial Details

NCT number	NCT05302999
Study type	Interventional
Source	MetroHealth Medical Center
Contact	Megan Hammond, M.Ed
Phone	216-957-3562
Email	mhammond1@metrohealth.org
Status	Recruiting
Phase	Phase 4
Start date	March 14, 2022
Completion date	August 31, 2026

View Details

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