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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two medications, Gabapentin and Oxcarbazepine, in reducing pain for children and teens with chronic neuropathic pain. Researchers aim to determine if these drugs can significantly lower pain levels and improve daily activities compared to a placebo (a non-active substance). Participants should be children aged 8 to 18 who experience moderate to severe long-lasting nerve-related pain, such as Complex Regional Pain Syndrome or Fibromyalgia. The study also examines how the treatments might affect mood and cognitive functions like memory and attention. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking pain management solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that gabapentin can cause mild to moderate side effects, such as dizziness and sleepiness. These effects usually occur early in treatment and tend to diminish over time. Gabapentin has also been linked to fewer negative effects compared to other pain treatments, allowing many people to tolerate it well.

Oxcarbazepine has effectively reduced pain, but it can also cause side effects. Common ones include dizziness, nausea, headache, and tiredness. In some studies, about 17% of patients stopped using it due to these side effects.

Both gabapentin and oxcarbazepine are generally well-tolerated, but like any medication, they can have side effects. Prospective trial participants should consider these potential risks alongside the benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Gabapentin and Oxcarbazepine for neuropathic pain because these drugs offer a different approach compared to the usual treatments like antidepressants and opioids. Gabapentin, for instance, targets calcium channels in the nervous system, potentially reducing pain by altering nerve signaling. Oxcarbazepine, on the other hand, stabilizes electrical activity in the brain, which can help manage pain effectively. These mechanisms could offer pain relief with potentially fewer side effects, providing a promising alternative to the standard treatments.

What evidence suggests that Gabapentin and Oxcarbazepine could be effective treatments for neuropathic pain?

Research has shown that Gabapentin, which participants in this trial may receive, can help reduce pain for conditions like diabetic nerve pain and pain after shingles. About 1 in 6 people with diabetic nerve pain and 1 in 8 with pain after shingles reported significant relief. Studies have found that Gabapentin can cut chronic pain by half, often leading to better sleep and easier daily activities. Oxcarbazepine, another treatment option in this trial, has shown in some studies to reduce pain more than a placebo, but results varied. One study found it lowered pain by 0.7 points on a scale of 0 to 10. Both Gabapentin and Oxcarbazepine can help manage nerve pain, but their effectiveness may vary depending on the person and condition. ^{4 6 7 8 9}

Who Is on the Research Team?

Monique Ribeiro, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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, 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11747324/

Pregabalin vs. gabapentin in the treatment of neuropathic pain Additionally, it improved patient-reported outcomes, resulted in lower opioid consumption, and led to fewer adverse events.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11783808/

Gabapentin for neuropathic pain: systematic review of ... The meta-analysis of the 2 high-quality, placebo-controlled RCTs showed positive effect of gabapentin in diabetic neuropathy and post-herpetic neuralgia.

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/188227

Gabapentin for the Symptomatic Treatment of Painful ... Gabapentin monotherapy produced rapid onset of clinically meaningful pain relief with relatively minor and potentially avoidable adverse effects in this trial.

4. aafp.org aafp.org/pubs/afp/issues/2015/1201/od1.html

Gabapentin for Chronic Neuropathic Pain Studies show that 1 in 6 patients were helped with diabetic neuropathy and 1 in 8 were helped with postherpetic neuralgia. Find out more.

5. thennt.com thennt.com/nnt/gabapentin-chronic-neuropathic-pain/

Gabapentin for Chronic Neuropathic Pain Patients generally consider a 50% reduction in their chronic pain a useful outcome because it has been associated with important beneficial effects on sleep ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01588314

Safety and Efficacy of Gabapentin for Neuropathic Pain in ... The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain and reducing the use of opioid ...

7. cureus.com cureus.com/articles/417737-a-comparative-study-on-the-efficacy-safety-and-cost-effectiveness-of-gabapentin-and-pregabalin-in-the-treatment-of-neuropathic-pain

A Comparative Study on the Efficacy, Safety and Cost ... A Comparative Study on the Efficacy, Safety and Cost Effectiveness of Gabapentin and Pregabalin in the Treatment of Neuropathic Pain. Riya ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0304395902002555

Gabapentin in neuropathic pain syndromes: a randomised ... The most common adverse events were mild to moderate dizziness and somnolence, most of which were transient and occurred during the titration phase. This study ...

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK253444/

SUMMARY OF EVIDENCE - Gabapentin for Adults with ... - NCBI Gabapentin and pregabalin combined were associated with an increased risk of ataxia (relative risk [RR] 3.70; 95% CI 1.18 to 11.65) and a decreased risk of dry ...