Feasibility of Early Gabapentin for Spinal Cord Injury Recovery
This study is looking at whether giving gabapentin early after a spinal cord injury (SCI) is practical and safe. Gabapentin is a medicine often used for nerve pain after SCI. Researchers want to see if starting gabapentin within 5 days of injury and continuing it for 90 days could help with recovery. This study will help them plan a larger study in the future. You may be able to join if you are 18 or older, have a traumatic SCI of any type or severity, and can start the study medicine within 120 hours (5 days) of your injury. The study will measure how many people join, how well they stick to the treatment, and if there are any issues with the study design. The current recruitment status is unclear.
- Study design
- This study will involve about 42 participants and will compare gabapentin to an inactive substance (placebo). Participants will be randomly assigned to one of three groups.
- What's involved
- You would take the study medication for 90 days, starting within 120 hours (5 days) of your injury.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for an additional 90 days after stopping treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of Early Gabapentin as an Intervention for Neurorecovery
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Dr. Kimberly Anderson, PhD · PRINCIPAL_INVESTIGATOR · Metrohealth Medical Center-Case Western Reserve University School of Medicine
Who to contact
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What this trial measures
- Number of participants recruitedDuring 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 protocolAcross 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 unblindingAcross 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
- Retention rateAcross 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