42 Participants Needed

Gabapentin for Spinal Cord Injury Neurorecovery

MH
DN
Overseen ByDan Nwosu, MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: MetroHealth Medical Center
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already using gabapentinoids (a type of medication that includes gabapentin) at the time of injury.

Is gabapentin generally safe for humans?

Gabapentin is generally well tolerated in humans, with common side effects including dizziness and tiredness. It has been used safely for conditions like neuropathic pain and spasticity in spinal cord injury patients.12345

How is the drug gabapentin unique for spinal cord injury recovery?

Gabapentin is unique for spinal cord injury recovery because it is being explored for its potential to promote neurological recovery when given early after injury, rather than just for pain management. This trial is testing its use in low-medium doses specifically for neurorecovery, which is different from its traditional use for pain relief.12678

What data supports the effectiveness of the drug gabapentin for spinal cord injury neurorecovery?

Gabapentin is already used to manage neuropathic pain in various conditions, including spinal cord injury, and emerging data suggests it may help with neurological recovery if given early after the injury. Additionally, studies have shown gabapentin provides better pain relief and improves sleep quality compared to a placebo.13789

Who Is on the Research Team?

DK

Dr. Kimberly Anderson, PhD

Principal Investigator

Metrohealth Medical Center-Case Western Reserve University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a spinal cord injury due to trauma.
I agree to start the study medication within 5 days after my injury.
All levels of SCI
See 2 more

Exclusion Criteria

I was taking gabapentinoids when I got injured.
I had a severe head injury with a low coma score.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive gabapentin or placebo for 90 days, starting within 5 days post-injury

12 weeks
Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Gabapentin
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Medium doseExperimental Treatment1 Intervention
Group II: Low doseExperimental Treatment1 Intervention
Group III: ControlPlacebo Group1 Intervention

Gabapentin is already approved in United States, European Union, Canada for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Neurontin for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Gabapentin for:
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Gabapentin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials
125
Recruited
22,600+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials
83
Recruited
10,500+

Published Research Related to This Trial

This trial is the first to explore the feasibility of using gabapentin, an FDA-approved medication, for promoting neurorecovery in spinal cord injury patients, rather than for pain management, with 42 participants enrolled and treated within 120 hours post-injury.
Participants will be randomly assigned to receive either 600 mg or 1,800 mg of gabapentin or a placebo for 90 days, with assessments at multiple time points to evaluate the feasibility of the trial and inform future efficacy studies.
Feasibility of gabapentin as an intervention for neurorecovery after an acute spinal cord injury: Protocol.Wilson, JR., Doty, S., Petitt, JC., et al.[2022]
In a study of 201 spinal cord injury patients, early administration of gabapentinoids (within 30 days) was linked to improved motor recovery, with an increase of 3.69 motor points compared to those who did not receive the medication.
The benefits of gabapentinoids were even greater when given within the first 5 days after injury, suggesting that earlier treatment may lead to better recovery outcomes.
Association of timing of gabapentinoid use with motor recovery after spinal cord injury.Warner, FM., Cragg, JJ., Jutzeler, CR., et al.[2021]
In a study involving 120 patients with neuropathic pain from nerve injury, gabapentin showed significant pain relief compared to placebo, with a notable reduction in pain interference with sleep.
While there was no significant difference in the primary pain intensity score, both patients and clinicians reported better overall improvement with gabapentin, and it was well tolerated with common side effects being dizziness and tiredness.
Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study.Gordh, TE., Stubhaug, A., Jensen, TS., et al.[2021]

Citations

Feasibility of gabapentin as an intervention for neurorecovery after an acute spinal cord injury: Protocol. [2022]
Association of timing of gabapentinoid use with motor recovery after spinal cord injury. [2021]
Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. [2021]
Use of gabapentin in the treatment of neuropathic pain. [2018]
Long-term use of gabapentin for treatment of pain after traumatic spinal cord injury. [2022]
Gabapentin for the treatment of spasticity in patients with spinal cord injury. [2019]
Using gabapentin to treat neuropathic pain. [2018]
Pregabalin and gabapentin in neuropathic pain management after spinal cord injury: a systematic review and meta-analysis. [2020]
Inhibitory effect of gabapentin on N-methyl-D-aspartate receptors expressed in Xenopus oocytes. [2022]
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