Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days. | Drug: Gabapentin<br>* Generic gabapentin<br>|
| Experimental: Medium dose<br>1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days. | Drug: Gabapentin<br>* Generic gabapentin<br>|
| Placebo Comparator: Control<br>The control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days. | Drug: Placebo<br>* Inert cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recruited | 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 | During the first 120 hours post-injury | 
| Adherence rate to drug treatment protocol | 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 | Across 90 day treatment window | 
| Number of occurrences of unblinding | 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 | Across 6 month study duration per participant | 
| Retention rate | 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 | Across 6 month study duration per participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin, Neurorecovery, Feasibility