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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Early Gabapentin as an Intervention for Neurorecovery
- ClinicalTrials.gov ID
- NCT05302999
- Acronym / sponsor ID
- IRB21-00609
- Conditions
- Spinal Cord Injuries
- Keywords
- Gabapentin, Neurorecovery, Feasibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: Gabapentin600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days. |
| Medium dose | Experimental | Drug: Gabapentin1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days. |
| Control | Placebo comparator | Drug: PlaceboThe control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinGeneric gabapentin | Drug | Low dose, Medium dose |
| PlaceboInert cellulose | Drug | Control |
Primary outcome
Number of participants recruited
Time frame: During the first 120 hours post-injury
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
Adherence rate to drug treatment protocol
Time frame: Across 90 day treatment window
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
Number of occurrences of unblinding
Time frame: Across 6 month study duration per participant
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
Retention rate
Time frame: Across 6 month study duration per participant
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Derived from this study: PubMed 36419530Wilson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Kimberly Anderson, PhD principal investigator
Metrohealth Medical Center-Case Western Reserve University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Spinal Cord Injuries, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: During the first 120 hours post-injury). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.