Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2026-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Low dose

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

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Generic gabapentin

Medium dose

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

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Generic gabapentin

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inert cellulose

Interventions

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Gabapentin

Generic gabapentin

Intervention Type DRUG

Placebo

Inert cellulose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No