Clinical trial NCT02219373: Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study
Official title: Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Double-Blind, Randomized Clinical Effectiveness Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pediatric Chronic Neuropathic Pain
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patient's whose pain rates between moderate to severe at the time of inclusion (ranging from 4-10 in a numeric pain rating scale)
3. 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).
4. Child has age-appropriate spoken and written knowledge of English.
5. Parent may be able to utilize an interpreter if need be.

Exclusion Criteria:

1. Unstable psychiatric illness (suicidal ideation, disorganized behavior)
2. Uncontrolled Seizure disorder
3. Chronic Headaches only
4. Abdominal Pain only
5. Prior experience with anticonvulsants for pain treatment.
6. Patients with Syndrome of Inappropriate Secretion of Antidiuretic Hormone

Primary outcomes:
measure: As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores
timeFrame: 0 (baseline), 2, 4, 6, 8 weeks (post-assignment of intervention)
Secondary outcomes:
measure: Pain Scores at rest and evoked maneuvers
timeFrame: 0 (baseline) and 4 and 8 weeks (post assignment of intervention)
measure: Frequency of side effects- Tolerability
timeFrame: 1, 2, 4, 6, 8 weeks (post assignment of intervention)
measure: Functional Disability Scores
timeFrame: 0 (baseline), 4, and 8 weeks (post-assignment of intervention)
measure: Frequency of Side effects- Depression and Anxiety
timeFrame: Baseline, Week 4 and 8 (post assignment of the intervention)
measure: Frequency of Side Effects- Neuropsychological Measures
timeFrame: Baseline, weeks 4 and 8 (post-assignment of the intervention).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Monique Ribeiro, MD
role: PRINCIPAL_INVESTIGATOR
References: