Feasibility of Early Gabapentin as an Intervention for Neurorecovery

November 24, 2025 updated by: Kimberly Anderson, PhD, MetroHealth Medical Center
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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