Gabapentin + Oxcarbazepine for Neuropathic Pain

Overseen By Monique Ribeiro, MD

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Boston Children's Hospital

Disqualifiers: Unstable psychiatric illness, Uncontrolled seizure disorder, Chronic headaches, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Given the widespread use of anticonvulsants in the pediatric chronic pain population and the absence of scientific data supporting their use, the investigators propose a randomized, double blind, two group parallel design in which a broad group of children and adolescents with chronic neuropathic pain would be randomized to receive either Gabapentin or Oxcarbazepine. The Primary Aim of the Study is to assess the frequencies of successful treatment of pediatric patients with neuropathic pain treated with either Gabapentin or Oxcarbazepine. The Primary Hypotheses are as follows: Hypothesis I: Both Gabapentin and Oxcarbazepine will result in significant reduction in pain scores when compared to each patient's baseline. Hypothesis II: Patients who continue on active drug (Gabapentin or Oxcarbazepine) during the second phase of the trial will report greater pain reduction relative to baseline than patients who are randomized onto placebo at this randomization point. Secondary Aims of the Study are to compare groups treated initially with Gabapentin or Oxcarbazepine with regard to reduction in pain scores (both at rest and with evoked maneuvers), functional disability scores, tolerability, and measures of mood and cognitive functioning. Secondary Hypotheses are that Gabapentin and Oxcarbazepine differ in their effects on: 1. Pain scores at rest and with evoked maneuvers 2. Functional disability scores 3. Tolerability (frequencies of side-effects) 4. Depression and anxiety scales 5. Neuropsychological measures of cognitive processing speed, working memory, and attention.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have prior experience with anticonvulsants for pain treatment, you may not be eligible to participate.

What data supports the effectiveness of the drug Gabapentin for neuropathic pain?

Research shows that Gabapentin is effective in managing neuropathic pain, with studies highlighting its efficacy and tolerability, making it a useful option for patients. ^{1 2 3 4 5}

Is gabapentin safe for humans?

Gabapentin is generally considered safe and well-tolerated for neuropathic pain, but there are reports of mild side effects, including sexual dysfunction in some cases. ^{1 6 7 8 9}

How is the drug combination of Gabapentin and Oxcarbazepine unique for treating neuropathic pain?

The combination of Gabapentin and Oxcarbazepine is unique because it uses two anticonvulsant drugs that may work together to relieve neuropathic pain, potentially offering better pain management than using either drug alone. Gabapentin is known for its effectiveness in chronic neuropathic pain, while Oxcarbazepine is better tolerated than similar drugs and has shown effectiveness in certain types of neuropathic pain. ^{1 10 11 12 13}

Research Team

Monique Ribeiro, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for children and adolescents aged 8-18 with chronic neuropathic pain due to nerve injury or specific conditions like Complex Regional Pain Syndrome. They must understand English, rate their pain as moderate to severe, and have not used anticonvulsants for pain before. Those with unstable psychiatric issues, uncontrolled seizures, only headaches or abdominal pain, or certain hormonal disorders can't join.

Inclusion Criteria

My pain is moderate to severe currently.

I have a diagnosis related to severe nerve pain or injury.

My child can speak and write English as expected for their age.

Exclusion Criteria

I only suffer from chronic headaches.

I have used anticonvulsants for pain management before.

I have a condition where my body secretes too much of a hormone that controls urine production.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Gabapentin or Oxcarbazepine, with dose escalation and monitoring for pain reduction and side effects

8 weeks

Visits at baseline, 2, 4, 6, and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Gabapentin
• Oxcarbazepine
• Placebo

Trial Overview The study tests the effectiveness of Gabapentin and Oxcarbazepine in reducing neuropathic pain in young patients compared to a placebo. It's randomized and double-blind: participants won't know if they're getting one of the drugs or a placebo. The main goal is to see if these drugs lower pain scores from baseline levels.

Participant Groups

Group I: Oxcarbazepine Experimental Treatment 2 Interventions

Group II: Gabapentin Experimental Treatment 2 Interventions

Group III: Placebo Placebo Group 3 Interventions

Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.

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?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Findings from Research

Gabapentin has been shown to be effective in managing neuropathic pain across various conditions, with a total of 750 cases and 511 participants in controlled trials confirming its utility at doses up to 3.6 g per day.

It is generally well-tolerated with fewer significant drug-drug interactions compared to other anticonvulsants, making it a preferred option for treating neuropathic pain, especially in patients who do not respond to traditional treatments like tricyclic antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on gabapentin therapy of neuropathic pain. Guay, DR.[2006]

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]

Gabapentin, commonly prescribed for neuropathic pain, lacks sufficient evidence for its safety and efficacy, as many trial results, particularly regarding its harms, have not been fully reported.

This study aims to analyze and disclose adverse events from six previously unreported trials of gabapentin, using clinical study reports and individual participant data to provide a clearer understanding of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation. Mayo-Wilson, E., Chen, X., Qureshi, R., et al.[2022]

In a study involving outpatients with various neuropathic pain syndromes, administering gabapentin in four different doses (QID) significantly reduced average daily pain scores and sleep disturbances compared to a three-times-daily dosing method (TID).

The QID dosing method also led to fewer adverse effects, although it did not significantly change the frequency, severity, or duration of breakthrough pain compared to the TID method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of four different doses of gabapentin reduces awakening from breakthrough pain and adverse effects in outpatients with neuropathic pain during the initial titration. Yang, JY., Lee, WI., Shin, WK., et al.[2021]

Gabapentin, taken orally at doses of 1200-3600 mg per day for 4-12 weeks, can significantly reduce chronic neuropathic pain in patients with conditions like postherpetic neuralgia and painful diabetic neuropathy.

Patients using gabapentin experienced at least a 50% reduction in pain compared to placebo, with an improvement seen in 14% to 17% more patients, highlighting its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin for Chronic Neuropathic Pain. Moore, A., Derry, S., Wiffen, P.[2018]

References

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

Update on gabapentin therapy of neuropathic pain. [2006]

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

Gabapentin adjunctive therapy in neuropathic pain states. [2019]

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

Reversible acute renal allograft dysfunction due to gabapentin. [2018]

4. Canada pubmed.ncbi.nlm.nih.gov

Using gabapentin to treat neuropathic pain. [2018]

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

Gabapentin induced polyneuropathy. [2019]

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

Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation. [2022]

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

Administration of four different doses of gabapentin reduces awakening from breakthrough pain and adverse effects in outpatients with neuropathic pain during the initial titration. [2021]

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

Morphine, gabapentin, or their combination for neuropathic pain. [2022]

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

Gabapentin and sexual dysfunction: report of two cases. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Oxcarbazepine for neuropathic pain. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Oxcarbazepine in neuropathic pain. [2019]

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

Gabapentin for Chronic Neuropathic Pain. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Oxcarbazepine for neuropathic pain. [2018]