Feasibility of Early Gabapentin as an Intervention for Neurorecovery

MetroHealth Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Spinal Cord Injuries

Treatments: Drug: Gabapentin; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05302999

IRB21-00609

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups, including a placebo group

Low dose

Experimental group

Description:

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

Treatment:

Drug: Gabapentin

Medium dose

Experimental group

Description:

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

Treatment:

Drug: Gabapentin

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo