Spinal Cord InjuriesPhase 4NCT05302999
Feasibility of Early Gabapentin as an Intervention for Neurorecovery
A Phase 4 study testing Gabapentin in people with Spinal Cord Injuries, run by MetroHealth Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 31 Mar 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic SCI;
- All levels of SCI;
- All severities of SCI, AIS A-D;
- Age 18 years and older.
- Agree to participate and start study drug within 120 hours' post-injury.
- Adequate cognition and communication to provide informed consent
Who cannot join
- Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) < 13 at 120 hours' post-injury.
- Documented use of gabapentinoids at the time of injury.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Gabapentin, Placebo
- Keywords
- Gabapentin, Neurorecovery, Feasibility
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Generic gabapentin
PlaceboDrug
Inert cellulose
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days. Receives: Drug: Gabapentin |
| Medium dose | Experimental | 1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days. Receives: Drug: Gabapentin |
| Control | Placebo comparator | The control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first 120 hours post-injury
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
Measured: Across 90 day treatment window
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
Measured: Across 6 month study duration per participant
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
Measured: Across 6 month study duration per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start14 Mar 2022
- Primary completion10 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Kimberly Anderson, PhD, MetroHealth Medical Center
- Investigators
- Dr. Kimberly Anderson, PhD, Principal investigator, Metrohealth Medical Center-Case Western Reserve University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302999
- Sponsor's protocol ID
- IRB21-00609
- Status last verified
- Sep 2026
- First submitted
- 22 Feb 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson JR, Doty S, Petitt JC, El-Abtah M, Francis JJ, Sharpe MG, Kelly ML, Anderson KD. Feasibility of gabapentin as an intervention for neurorecovery after an acute spinal cord injury: Protocol. Front Neurol. 2022 Nov 7;13:1033386. doi: 10.3389/fneur.2022.1033386. eCollection 2022.
PubMed 36419530