Gabapentin for Spinal Cord Injury Neurorecovery

Overseen By Dan Nwosu, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: MetroHealth Medical Center

Must not be taking: Gabapentinoids

Disqualifiers: Moderate/severe TBI, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

42 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 2 5 6 9}

Research Team

Dr. Kimberly Anderson, PhD

Principal Investigator

Metrohealth Medical Center-Case Western Reserve University School of Medicine

Eligibility Criteria

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 am 18 years old or older.

I agree to start the study medication within 5 days after my injury.

Exclusion Criteria

I was taking gabapentinoids when I got injured.

I had a severe head injury with a low coma score.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Medium dose Experimental Treatment 1 Intervention

1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.

Group II: Low dose Experimental Treatment 1 Intervention

600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.

Group III: Control Placebo Group 1 Intervention

The control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days.

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

Approved in United States as Neurontin for:

• Postherpetic neuralgia
• Partial-onset seizures

Approved in European Union as Gabapentin for:

• Peripheral neuropathic pain
• Partial-onset seizures

Approved in Canada as Gabapentin for:

• Postherpetic neuralgia
• Partial-onset seizures

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Gabapentin has been found to be effective in treating various types of neuropathic pain, which is often difficult to manage with existing treatments.

It offers a favorable safety profile and minimal drug interactions compared to other therapies, although its cost and limited clinical experience may restrict its use as a first-line treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of gabapentin in the treatment of neuropathic pain. Laird, MA., Gidal, BE.[2018]

In a study of 31 patients with spinal cord injury treated with gabapentin, 67% reported a significant reduction in pain after the initial trial, indicating its potential efficacy as a long-term pain management option.

Despite some patients experiencing intolerable side effects leading to discontinuation, 91% of those who found gabapentin effective continued to report pain relief over a 3-year follow-up, suggesting it can be a viable treatment for those who tolerate it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of gabapentin for treatment of pain after traumatic spinal cord injury. Putzke, JD., Richards, JS., Kezar, L., et al.[2022]

In a study of 25 patients with spinal cord injury and spasticity, gabapentin administration resulted in an 11% reduction in spasticity as measured by the Ashworth Scale, indicating its potential efficacy in managing this condition (P = 0.04).

Patient-reported outcomes also showed a significant 20% reduction in spasticity on the Likert Scale (P = 0.0013), suggesting that gabapentin may be a beneficial treatment option for those who do not respond to or tolerate standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin for the treatment of spasticity in patients with spinal cord injury. Gruenthal, M., Mueller, M., Olson, WL., et al.[2019]

Gabapentin is an anticonvulsant medication that has been found to be an effective adjuvant treatment for neuropathic pain, despite the lack of double-blind studies specifically examining its analgesic properties.

It has favorable pharmacokinetic properties, is well tolerated with minimal drug interactions, making it a safe option for patients suffering from various neuropathic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using gabapentin to treat neuropathic pain. Hays, H., Woodroffe, MA.[2018]

Pregabalin (PGB) and gabapentin (GBP) are both effective treatments for neuropathic pain following spinal cord injury, showing significant improvements compared to placebo in pain, anxiety, depression, and sleep interference based on a meta-analysis of eight studies.

There was no significant difference in efficacy or adverse event discontinuation rates between PGB and GBP, suggesting that both medications can be considered equally viable options for managing neuropathic pain in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregabalin and gabapentin in neuropathic pain management after spinal cord injury: a systematic review and meta-analysis. Davari, M., Amani, B., Amani, B., et al.[2020]

Gabapentin (GBP) inhibits NMDA receptors in a concentration-dependent manner, which may be a key mechanism behind its pain-relieving effects, particularly in neuropathic and post-operative pain.

The study found that GBP does not affect GABA(A) and glycine receptors or GIRK channels, suggesting that these pathways are not involved in its analgesic properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory effect of gabapentin on N-methyl-D-aspartate receptors expressed in Xenopus oocytes. Hara, K., Sata, T.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of gabapentin as an intervention for neurorecovery after an acute spinal cord injury: Protocol. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Association of timing of gabapentinoid use with motor recovery after spinal cord injury. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Use of gabapentin in the treatment of neuropathic pain. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term use of gabapentin for treatment of pain after traumatic spinal cord injury. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Gabapentin for the treatment of spasticity in patients with spinal cord injury. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Using gabapentin to treat neuropathic pain. [2018]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Pregabalin and gabapentin in neuropathic pain management after spinal cord injury: a systematic review and meta-analysis. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Inhibitory effect of gabapentin on N-methyl-D-aspartate receptors expressed in Xenopus oocytes. [2022]