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Anti-epileptic

Gabapentin + Oxcarbazepine for Neuropathic Pain

Phase 3
Waitlist Available
Led By Monique Ribeiro, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients whose pain rates between moderate to severe at the time of inclusion
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 4, 6, 8 weeks (post assignment of intervention)
Awards & highlights

Study Summary

This trial is testing whether gabapentin or oxcarbazepine are effective in reducing pain for pediatric patients with neuropathic pain, and whether either drug is better than the other.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include dizziness, fatigue, nausea, mood changes (like depression or anxiety), cognitive impacts affecting memory and attention. Each drug has its own profile of potential side effects that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pain is moderate to severe currently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 4, 6, 8 weeks (post assignment of intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 4, 6, 8 weeks (post assignment of intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Secondary outcome measures
Frequency of Side Effects- Neuropsychological Measures
Frequency of Side effects- Depression and Anxiety
Frequency of side effects- Tolerability
+2 more

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: OxcarbazepineExperimental Treatment2 Interventions
Group II: GabapentinExperimental Treatment2 Interventions
Group III: PlaceboPlacebo Group3 Interventions
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
FDA approved
Oxcarbazepine
FDA approved

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
760 Previous Clinical Trials
5,579,620 Total Patients Enrolled
Monique Ribeiro, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

Gabapentin (Anti-epileptic) Clinical Trial Eligibility Overview. Trial Name: NCT02219373 — Phase 3
Neuropathic Pain Research Study Groups: Gabapentin, Placebo, Oxcarbazepine
Neuropathic Pain Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT02219373 — Phase 3
Gabapentin (Anti-epileptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02219373 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project open to people who are middle-aged?

"Eligibility for this clinical trial is based on age, with potential participants requiring to be aged between 8-18 years old."

Answered by AI

What conditions does Gabapentin typically treat?

"Gabapentin is effective in treating neuralgia, epilepsies, and postherpetic neuralgia."

Answered by AI

If a patient wanted to enroll today, would they be able to join the trial?

"This research is not currently enrolling patients. However, it is still listed on clinicaltrials.gov and was last updated on August 5th, 2022. There are 166 other studies concerning neuralgia that are actively recruiting participants as well as 28 trials for Gabapentin specifically."

Answered by AI

How many test subjects are needed for this experiment?

"Unfortunately, this trial is no longer enrolling patients. The study was first posted on 10/1/2022 and was last updated on 8/5/2022. However, there are 166 other trials for neuralgia and 28 for Gabapentin that are still admitting patients."

Answered by AI

Who meets the requirements to participate in this research project?

"This clinical trial is looking for 60 participants aged 8-18 who currently suffer from neuralgia. In addition to meeting this criteria, patients must also have moderate to severe pain (ranging from 4-10 in a numeric pain rating scale), be able to utilize an interpreter if needed, and have one of the following eligible diagnoses: Complex Regional Pain Syndrome, Fibromyalgia, Lumbar Radiculopathy, Spinal cord injury, Erythromelalgia, Small Fiber Neuropathies, Traumatic or Post-surgical Peripheral Nerve or Plexus Injuries, and Extremity Pain with severe pain"

Answered by AI

Does Gabapentin put patients at risk for any adverse health conditions?

"We believe that Gabapentin is safe to use because it has gone through Phase 3 trials. This means that not only is there some evidence supporting its efficacy, but also that multiple rounds of testing have confirmed its safety."

Answered by AI
~40 spots leftby Dec 2025