Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Phase 4

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT05302999
• Lead Sponsor: MetroHealth Medical Center

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. 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.

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 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 Timeline

• Study First Submitted: 2022-02-22
• Study Start: 2022-03-14
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Traumatic SCI;
2. All levels of SCI;
3. All severities of SCI, AIS A-D;
4. Age 18 years and older.
5. Agree to participate and start study drug within 120 hours' post-injury.
6. Adequate cognition and communication to provide informed consent

Exclusion Criteria

1. Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) < 13 at 120 hours' post-injury.
2. Documented use of gabapentinoids at the time of injury.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	The control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days.
Low dose	Gabapentin	600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.
Medium dose	Gabapentin	1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.

Primary Outcome Measures

Name	Time	Method
Retention rate	Across 6 month study duration per participant	Feasibility question - Will participants complete the study?; Feasibility measure - Retention rate; reasons for dropout; proportion of planned assessments completed; Quantitative benchmark of success - 70% of participants stay enrolled until the end of the study and complete 3 of the 4 assessment visits
Number of participants recruited	During the first 120 hours post-injury	Feasibility question - Can the target population be recruited?; Feasibility measure - Number screened/month; number enrolled/month; reasons for not enrolling; Quantitative benchmark of success - Screen an average of 4/month; Enroll an average of 1/month
Adherence rate to drug treatment protocol	Across 90 day treatment window	Feasibility question - Can the drug treatment protocol be delivered?; Feasibility measure - Proportion of enrolled who receive the full drug treatment protocol (placebo arm; two gabapentin dose arms); number of dosing deviations/arm; reasons for dosing deviations; Quantitative benchmark of success - 70% enrolled in placebo arm receive full dosing protocol; 70% enrolled in each gabapentin arm receive full dosing protocol
Number of occurrences of unblinding	Across 6 month study duration per participant	Feasibility question - Can the assessors remain blinded?; Feasibility measure - Number of occurrences of unblinding; reasons for unblinding; Quantitative benchmark of success - 5% or fewer occurrences of unblinding

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States