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Gabapentin for Spinal Cord Injury Neurorecovery

Phase 4
Recruiting
Led By Dr. Kimberly Anderson, PhD
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Traumatic SCI
Age 18 years and older
Must not have
Documented use of gabapentinoids at the time of injury
Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) < 13 at 120 hours' post-injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up across 6 month study duration per participant
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved

Summary

This trial will test whether gabapentin can help with neurorecovery, and whether it is feasible to conduct a well-designed study on the efficacy of the intervention in the future.

Who is the study for?
This trial is for adults who have experienced a traumatic spinal cord injury (SCI) of any level or severity, and can start the study drug within 120 hours after their injury. They must be able to understand and agree to participate in the trial. People with moderate/severe brain injuries or those already using gabapentinoids at the time of injury cannot join.
What is being tested?
The study is testing whether taking Gabapentin early on can help with nerve recovery after a spinal cord injury. Participants will either receive Gabapentin or a placebo, which has no active ingredients, to see if there's a difference in recovery outcomes.
What are the potential side effects?
While not specified here, common side effects of Gabapentin may include dizziness, fatigue, and coordination problems. The placebo group should not experience medication-related side effects since it contains no active drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a spinal cord injury due to trauma.
Select...
I am 18 years old or older.
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My spinal cord injury ranges from complete to incomplete.
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I understand the information given to me and can communicate my decision.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I was taking gabapentinoids when I got injured.
Select...
I had a severe head injury with a low coma score.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~across 6 month study duration per participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and across 6 month study duration per participant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment Protocols
Number of occurrences of unblinding
Number of participants recruited
+1 more

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Medium doseExperimental Treatment1 Intervention
1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.
Group II: Low doseExperimental Treatment1 Intervention
600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.
Group III: ControlPlacebo Group1 Intervention
The control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
FDA approved

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
120 Previous Clinical Trials
22,034 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
81 Previous Clinical Trials
10,141 Total Patients Enrolled
Dr. Kimberly Anderson, PhDPrincipal InvestigatorMetrohealth Medical Center-Case Western Reserve University School of Medicine

Media Library

Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05302999 — Phase 4
Spinal Cord Injury Research Study Groups: Low dose, Medium dose, Control
Spinal Cord Injury Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT05302999 — Phase 4
Gabapentin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05302999 — Phase 4
~16 spots leftby Aug 2026
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