Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Spinal Cord Injuries Clinical Trial

Official title:

Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302999
• Other study ID #: IRB21-00609
• Status: Recruiting
• Phase: Phase 4
• Start date: March 14, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: June 2024
• Source: MetroHealth Medical Center
• Contact: Megan Hammond, M.Ed
• Phone: 216-957-3562
• Email: mhammond1[@]metrohealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Drug:
• Gabapentin
Generic gabapentin
• Placebo
Inert cellulose

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
MetroHealth Medical Center	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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