Clinical trial NCT05302999: Feasibility of Early Gabapentin as an Intervention for Neurorecovery
Official title: Feasibility of Early Gabapentin as an Intervention for Neurorecovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Spinal Cord Injuries
Keywords: Gabapentin
Neurorecovery
Feasibility
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2022-03-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants recruited
timeFrame: During the first 120 hours post-injury
measure: Adherence rate to drug treatment protocol
timeFrame: Across 90 day treatment window
measure: Number of occurrences of unblinding
timeFrame: Across 6 month study duration per participant
measure: Retention rate
timeFrame: Across 6 month study duration per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: Metrohealth Medical Center-Case Western Reserve University School of Medicine
name: Dr. Kimberly Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: