Gabapentin for Spinal Cord Injury Neurorecovery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: MetroHealth Medical Center
Must not be taking: Gabapentinoids
Disqualifiers: Moderate/severe TBI, others
Prior Safety Data
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.
12345Is 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.
13678How 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.
12569Eligibility 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.
+3 more
Exclusion Criteria
I was taking gabapentinoids when I got injured.
I had a severe head injury with a low coma score.
Trial 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)
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MetroHealth Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
MetroHealth Medical CenterLead Sponsor
National Institute on Disability, Independent Living, and Rehabilitation ResearchCollaborator
References
Feasibility of gabapentin as an intervention for neurorecovery after an acute spinal cord injury: Protocol. [2022]This protocol is describing the first ever prospective, mock-efficacy, dose exploration trial design testing the feasibility of administering gabapentin in the acute setting as an intervention for neurorecovery. Gabapentin is an FDA-approved medication for treating seizures and postherpetic neuralgia and is used broadly off-label for neuropathic pain management for many conditions, including spinal cord injury. Emerging data suggests that when given early after spinal cord injury onset and in low-medium doses, gabapentin may have properties that promote recovery of neurological function. The objective of this trial is to assess the feasibility of conducting an efficacy trial in which gabapentin is started early after injury, is restricted in its dose, and is not used for pain management.
Association of timing of gabapentinoid use with motor recovery after spinal cord injury. [2021]To explore the hypothesis that earlier administration of acute gabapentinoids is beneficial to motor recovery after spinal cord injury in humans.
Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. [2021]A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p=0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p=0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p=0.0016). Both the Patient (p=0.023) and Clinician (p=0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness.
Use of gabapentin in the treatment of neuropathic pain. [2018]To evaluate the role of gabapentin for the treatment of neuropathic pain.
Long-term use of gabapentin for treatment of pain after traumatic spinal cord injury. [2022]To determine the long-term efficacy of gabapentin as a treatment of pain after spinal cord injury.
Gabapentin for the treatment of spasticity in patients with spinal cord injury. [2019]Our serendipitous observations suggested that some patients with spasticity appeared to have improved following the administration of the anticonvulsant drug gabapentin. As some patients with spasticity are either refractory to or intolerant of established medical treatments, we conducted this study to investigate the effect of gabapentin on spasticity in patients with spinal cord injury. Twenty-five patients with spinal cord injury and spasticity received oral gabapentin (2400 mg over 48 h) in a randomized, double blind, placebo-controlled crossover study. We assessed responses by measuring the Ashworth spasticity scale, muscle stretch reflexes, presence of clonus and reflex response to noxious stimuli. Patient ratings were obtained using a Likert Scale. Administration of gabapentin, but not placebo, was associated with an 11% reduction in spasticity as measured by the Ashworth Scale (P = 0.04) and by a 20% reduction in the Likert Scale (P = 0.0013). Significant changes were not obtained for the other measures. The data obtained suggest that gabapentin may be useful in the management of spasticity associated with spinal cord injury.
Using gabapentin to treat neuropathic pain. [2018]To review use of gabapentin as an adjuvant agent to treat neuropathic pain.
Pregabalin and gabapentin in neuropathic pain management after spinal cord injury: a systematic review and meta-analysis. [2020]Neuropathic pain after spinal cord injury (SCI) has a significant negative impact on the patients' quality of life. The objective of this systematic review is to examine the safety and efficacy of pregabalin (PGB) and gabapentin (GBP) in the treatment of neuropathic pain due to SCI. PubMed, the Cochrane Library, Embase, Scopus, and the Web of Science were searched up to December 2018. The reference lists of key and review studies were reviewed for additional citations. The quality of the studies was evaluated using the Cochrane Collaboration's tools for assessing the risk of bias. A meta-analysis was performed for primary and secondary outcomes. Eight studies were eligible for inclusion. Meta-analysis of PGB vs. placebo showed that PGB was effective for neuropathic pain (standardized mean difference [SMD] = -0.40; 95% confidence interval [CI]: -0.78, -0.01), anxiety (MD = -0.68; 95% CI: -0.77, -0.59), depression (mean difference [MD] = -0.99; 95% CI: -1.08, -0.89), and sleep interference (MD = -1.08; 95% CI: -1.13, -1.02). Also, GBP was more effective than a placebo for reducing pain. No significant difference was observed between the efficacy of the two drugs (MD = -0.37; 95% CI: -1.67, 0.93). There was no significant difference between the two drugs for discontinuation due to adverse events (risk ratio = 3.00; 95% CI: 0.81, 11.15). PGB and GBP were effective vs. placebos in decreasing neuropathic pain after SCI. Also, there was no significant difference between the two drugs for decreasing pain and adverse events.
Inhibitory effect of gabapentin on N-methyl-D-aspartate receptors expressed in Xenopus oocytes. [2022]Gabapentin (GBP) is a prescription drug used for the treatment of neuropathic and post-operative pain. However, the mechanism by which it exerts its analgesic action is not well understood. Because intrathecal administration of GBP has been shown to exert antinociceptive effects in animal studies, we hypothesized that the spinal cord may be a plausible action site.