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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05302999
Other study ID # IRB21-00609
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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