Recruiting

Gabapentin

Sponsor:

MetroHealth Medical Center

Code:

NCT05302999

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gabapentin

Placebo

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Study ID

NCT05302999

Start date

Mar 14, 2022

Status verified date

Nov, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low dose

600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.

experimental: Medium dose

1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.

placebo comparator: Control

The control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days.

Interventions

Gabapentin

Generic gabapentin

Placebo

Inert cellulose

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mayson Moore

216-957-3518mmoore12@metrohealth.org

Locations

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Mayson Moore

216-957-3518mmoore12@metrohealth.org

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

  • Gabapentin
  • Neurorecovery
  • Feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2025-12-02.