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NCT Number: NCT05302999

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location status: Recruiting

Location contact

Mayson Moore

CONTACT

[email protected]

216-957-3518

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

Generic gabapentin

Placebo

Drug

Inert cellulose

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mayson Moore

CONTACT

[email protected]

216-957-3518

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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