Feasibility of Early Gabapentin as an Intervention for Neurorecovery

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Drug: Gabapentin; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mayson Moore; Phone Number: 216-957-3518; Email: mmoore12@metrohealth.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Recruiting
      • MetroHealth Medical Center
      • Contact: Mayson Moore; Phone Number: 216-957-3518; Email: mmoore12@metrohealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MetroHealth Medical Center
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Dr. Kimberly Anderson, PhD, Metrohealth Medical Center-Case Western Reserve University School of Medicine

Publications and helpful links

General Publications

• Wilson JR, Doty S, Petitt JC, El-Abtah M, Francis JJ, Sharpe MG, Kelly ML, Anderson KD. Feasibility of gabapentin as an intervention for neurorecovery after an acute spinal cord injury: Protocol. Front Neurol. 2022 Nov 7;13:1033386. doi: 10.3389/fneur.2022.1033386. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Feasibility; Gabapentin; Neurorecovery
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Amino Acids, Peptides, and Proteins; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Amines; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Gabapentin
• Other Study ID Numbers: IRB21-00609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes