Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study

NCT02219373 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: P00008001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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. 1.Pain scores at rest and with evoked maneuvers
2. 2.Functional disability scores
3. 3.Tolerability (frequencies of side-effects)
4. 4.Depression and anxiety scales
5. 5.Neuropsychological measures of cognitive processing speed, working memory, and attention.

Conditions

Pediatric Chronic Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores

  1. 2 point reduction in average daily pain scores 2. 30% reduction relative to baseline 3. Global overall impression of strong benefit.

  0 (baseline), 2, 4, 6, 8 weeks (post-assignment of intervention)

Secondary Outcomes (5)

• Pain Scores at rest and evoked maneuvers

  0 (baseline) and 4 and 8 weeks (post assignment of intervention)

• Frequency of side effects- Tolerability

  1, 2, 4, 6, 8 weeks (post assignment of intervention)

• Functional Disability Scores

  0 (baseline), 4, and 8 weeks (post-assignment of intervention)

• Frequency of Side effects- Depression and Anxiety

  Baseline, Week 4 and 8 (post assignment of the intervention)

• Frequency of Side Effects- Neuropsychological Measures

  Baseline, weeks 4 and 8 (post-assignment of the intervention).

Study Arms (3)

Gabapentin

EXPERIMENTAL

Drug: Gabapentin; Other: Placebo

Oxcarbazepine

EXPERIMENTAL

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.

Drug: Gabapentin; Drug: Oxcarbazepine; Other: Placebo

Interventions

Placebo OTHER

Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.

Gabapentin; Oxcarbazepine; Placebo

Gabapentin DRUG

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.

Gabapentin; Placebo

Oxcarbazepine DRUG

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.

Oxcarbazepine; Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Gabapentin; Oxcarbazepine

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Monique Ribeiro, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monique Ribeiro, MD

CONTACT

(617) 355-7040; Monique.Ribeiro@childrens.harvard.edu

Kimberly Lobo, MPH

CONTACT

(857) 218-3556; Kimberly.Lobo@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 18, 2014
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)