Pediatric Chronic Neuropathic PainPhase 3NCT02219373
Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study
A Phase 3 study testing Gabapentin and Oxcarbazepine in people with Pediatric Chronic Neuropathic Pain, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pediatric Chronic Neuropathic Pain
- What is being tested?
- Gabapentin and Oxcarbazepine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the ages of 8 and 18 at the time of the study with history of chronic (lasting ≥ 4 weeks) neuropathic pain that includes a known injury to a peripheral nerve and/or a pattern of pain responses that includes allodynia, burning, paresthesias or dysesthesias will be included in this study, provided that informed consent has been given by parents.
- Patient's whose pain rates between moderate to severe at the time of inclusion (ranging from 4-10 in a numeric pain rating scale)
- Eligible diagnoses include 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 to light touch (allodynia).
- Child has age-appropriate spoken and written knowledge of English.
- Parent may be able to utilize an interpreter if need be.
Who cannot join
- Unstable psychiatric illness (suicidal ideation, disorganized behavior)
- Uncontrolled Seizure disorder
- Chronic Headaches only
- Abdominal Pain only
- Prior experience with anticonvulsants for pain treatment.
- Patients with Syndrome of Inappropriate Secretion of Antidiuretic Hormone
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Double-Blind, Randomized Clinical Effectiveness Study.
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.
Read more
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:
- Pain scores at rest and with evoked maneuvers
- Functional disability scores
- Tolerability (frequencies of side-effects)
- Depression and anxiety scales
- Neuropsychological measures of cognitive processing speed, working memory, and attention.
- Conditions
- Pediatric Chronic Neuropathic Pain
- Being tested
- Gabapentin, Oxcarbazepine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Patients will be randomized to receive either Gabapentin or Oxcarbazepine. The assignment of the medications will be randomized and blinded to both the study investigators and the patient. If patients exhibit >30% pain reduction on receiving the medication evaluated after 4 weeks, then they may continue to receive either the same medication or placebo. If patients exhibit <30% pain reduction, the patient will crossover to the other medication option in the protocol.
OxcarbazepineDrug
Patients will be randomized to receive either Gabapentin or Oxcarbazepine. The assignment of the medications will be randomized and blinded to both the study investigators and the patient. If patients exhibit >30% pain reduction on receiving the medication evaluated after 4 weeks, then they may continue to receive either the same medication or placebo. If patients exhibit <30% pain reduction, the patient will crossover to the other medication option in the protocol.
PlaceboOther
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Not described Receives: Drug: Gabapentin; Other: Placebo |
| Oxcarbazepine | Experimental | Not described Receives: Drug: Oxcarbazepine; Other: Placebo |
| Placebo | Placebo comparator | Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs. Receives: Drug: Gabapentin; Drug: Oxcarbazepine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores
- 2 point reduction in average daily pain scores
- 30% reduction relative to baseline
- Global overall impression of strong benefit.
Measured: 0 (baseline), 2, 4, 6, 8 weeks (post-assignment of intervention)
Secondary outcomes (5)
Pain Scores at rest and evoked maneuvers
The investigators will assess pain scores at rest and with evoked maneuvers through exam and quantitative sensory test.
Measured: 0 (baseline) and 4 and 8 weeks (post assignment of intervention)
Frequency of side effects- Tolerability
- Common side effects include headaches and feeling sleepier in the morning and having less energy. Side effects that can occur, but are not common, include gastrointestinal side effects (upset stomach or throwing up, diarrhea or constipation, and weight gain), feeling lightheaded, having blurred eyesight, shakiness or changes in balance.
- Very rarely, patients taking these medicines may experience memory problems, sadness, nervousness, and Serious Adverse Events (SAEs).
Routine laboratory testing will be conducted as part of the safety profile assessment.
Measured: 1, 2, 4, 6, 8 weeks (post assignment of intervention)
Functional Disability Scores
Measured: 0 (baseline), 4, and 8 weeks (post-assignment of intervention)
Frequency of Side effects- Depression and Anxiety
As both study medicines may be associated with mood changes and as pain itself sometimes is co-morbid with anxiety and depression, the investigators will perform self-report measures of anxiety and depression (Children's Depressive Inventory and The Revised Children's Manifest Anxiety Scale) pre and post-assigment of the intervention.
Measured: Baseline, Week 4 and 8 (post assignment of the intervention)
Frequency of Side Effects- Neuropsychological Measures
Both study medicines may be associated with the emergence of cognitive side effects to include difficulties with concentration and cognitive slowing. The investigators will assess for cognitive processing speed, working memory and attention difficulties during the course of treatment using the NIH toobox Cognitive Battery.
Measured: Baseline, weeks 4 and 8 (post-assignment of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJun 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Study was withdrawn for feasibility-related concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Chronic Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Ribeiro, Boston Children's Hospital
- Investigators
- Monique Ribeiro, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219373
- Sponsor's protocol ID
- P00008001
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2014
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Double-Blind, Randomized Clinical Effectiveness Study.
- ClinicalTrials.gov ID
- NCT02219373
- Acronym / sponsor ID
- P00008001
- Conditions
- Pediatric Chronic Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn for feasibility-related concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pain scores at rest and with evoked maneuvers
- Functional disability scores
- Tolerability (frequencies of side-effects)
- Depression and anxiety scales
- Neuropsychological measures of cognitive processing speed, working memory, and attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin, Other: Placebo |
| Oxcarbazepine | Experimental | Drug: Oxcarbazepine, Other: Placebo |
| Placebo | Placebo comparator | Drug: Gabapentin, Drug: Oxcarbazepine, Other: PlaceboPatients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients between the ages of 8 and 18 at the time of the study with history of chronic (lasting ≥ 4 weeks) neuropathic pain that includes a known injury to a peripheral nerve and/or a pattern of pain responses that includes allodynia, burning, paresthesias or dysesthesias will be included in this study, provided that informed consent has been given by parents.
- Patient's whose pain rates between moderate to severe at the time of inclusion (ranging from 4-10 in a numeric pain rating scale)
- Eligible diagnoses include 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 to light touch (allodynia).
- Child has age-appropriate spoken and written knowledge of English.
- Parent may be able to utilize an interpreter if need be.
Key exclusion criteria (6 listed)
- Unstable psychiatric illness (suicidal ideation, disorganized behavior)
- Uncontrolled Seizure disorder
- Chronic Headaches only
- Abdominal Pain only
- Prior experience with anticonvulsants for pain treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinPatients will be randomized to receive either Gabapentin or Oxcarbazepine. The assignment of the medications will be randomized and blinded to both the study investigators and the patient. If patients exhibit >30% pain reduction on receiving the medication evaluated after 4 weeks, then they may continue to receive either the same medication or placebo. If patients exhibit <30% pain reduction, the patient will crossover to the other medication option in the protocol. | Drug | Gabapentin, Placebo |
| OxcarbazepinePatients will be randomized to receive either Gabapentin or Oxcarbazepine. The assignment of the medications will be randomized and blinded to both the study investigators and the patient. If patients exhibit >30% pain reduction on receiving the medication evaluated after 4 weeks, then they may continue to receive either the same medication or placebo. If patients exhibit <30% pain reduction, the patient will crossover to the other medication option in the protocol. | Drug | Oxcarbazepine, Placebo |
| PlaceboPatients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs. | Other | Gabapentin, Oxcarbazepine, Placebo |
Primary outcome
As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores
Time frame: 0 (baseline), 2, 4, 6, 8 weeks (post-assignment of intervention)
1. 2 point reduction in average daily pain scores 2. 30% reduction relative to baseline 3. Global overall impression of strong benefit.
5 secondary outcomes
Pain Scores at rest and evoked maneuvers
Time frame: 0 (baseline) and 4 and 8 weeks (post assignment of intervention)
Frequency of side effects- Tolerability
Time frame: 1, 2, 4, 6, 8 weeks (post assignment of intervention)
Functional Disability Scores
Time frame: 0 (baseline), 4, and 8 weeks (post-assignment of intervention)
Frequency of Side effects- Depression and Anxiety
Time frame: Baseline, Week 4 and 8 (post assignment of the intervention)
Frequency of Side Effects- Neuropsychological Measures
Time frame: Baseline, weeks 4 and 8 (post-assignment of the intervention).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique Ribeiro, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin and Oxcarbazepine in people with Pediatric Chronic Neuropathic Pain, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores (time frame: 0 (baseline), 2, 4, 6, 8 weeks (post-assignment of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.