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

Conditions

• Pediatric Chronic Neuropathic Pain

Eligibility Criteria

Sex

ALL

Age

8 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Gabapentin
• Experimental: Oxcarbazepine
• Placebo Comparator: Placebo
  Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.

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) ]

Central Contacts

• Monique Ribeiro, MD
  (617) 355-7040
  [email protected]
• Kimberly Lobo, MPH
  (857) 218-3556
  [email protected]

Locations (1)

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