Gabapentin + Oxcarbazepine for Neuropathic Pain

Recruiting in Palo Alto (17 mi)

Overseen by Monique Ribeiro, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boston Children's Hospital

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Children's Hospital Boston, MA

Who Is Running the Clinical Trial?

Boston Children's Hospital Lead Sponsor

References