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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
Must not have
Patients with Syndrome of Inappropriate Secretion of Antidiuretic Hormone
Uncontrolled Seizure disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 4, 6, 8 weeks (post assignment of intervention)
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition where my body secretes too much of a hormone that controls urine production.
Select...
I have seizures that are not controlled by medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain
Secondary study objectives
Frequency of Side Effects- Neuropsychological Measures
Frequency of Side effects- Depression and Anxiety
Frequency of side effects- Tolerability
+1 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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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
788 Previous Clinical Trials
5,582,511 Total Patients Enrolled
Monique Ribeiro, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

Gabapentin (Anti-epileptic) Clinical Trial Eligibility Overview. Trial Name: NCT02219373 — Phase 3
Pediatric neuropathic pain Research Study Groups: Gabapentin, Placebo, Oxcarbazepine
Pediatric 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
~40 spots leftby Dec 2025
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