Feasibility of Early Gabapentin as an Intervention for Neurorecovery

NCT05302999 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB21-00609
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Gabapentin; Neurorecovery; Feasibility

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Low dose

EXPERIMENTAL

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

Drug: Gabapentin

Medium dose

EXPERIMENTAL

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

Drug: Gabapentin

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Gabapentin DRUG

Generic gabapentin

Low dose; Medium dose

Placebo DRUG

Inert cellulose

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36419530 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Dr. Kimberly Anderson, PhD

  Metrohealth Medical Center-Case Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayson Moore

CONTACT

216-957-3518; mmoore12@metrohealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Northeast Ohio Regional SCI Model System

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 31, 2022
• Study Start: March 14, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)