- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219373
Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Monique Ribeiro, MD
- Phone Number: (617) 355-7040
- Email: Monique.Ribeiro@childrens.harvard.edu
Study Contact Backup
- Name: Kimberly Lobo, MPH
- Phone Number: (857) 218-3556
- Email: Kimberly.Lobo@childrens.harvard.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
Principal Investigator:
- Monique Ribeiro, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gabapentin
|
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.
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
|
Experimental: Oxcarbazepine
|
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
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 Comparator: Placebo
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
|
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.
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
|
0 (baseline), 2, 4, 6, 8 weeks (post-assignment of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores at rest and evoked maneuvers
Time Frame: 0 (baseline) and 4 and 8 weeks (post assignment of intervention)
|
The investigators will assess pain scores at rest and with evoked maneuvers through exam and quantitative sensory test.
|
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)
|
Routine laboratory testing will be conducted as part of the safety profile assessment. |
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)
|
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)
|
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.
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Baseline, Week 4 and 8 (post assignment of the intervention)
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Frequency of Side Effects- Neuropsychological Measures
Time Frame: Baseline, weeks 4 and 8 (post-assignment of the intervention).
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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.
|
Baseline, weeks 4 and 8 (post-assignment of the intervention).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Monique Ribeiro, MD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Antimanic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Gabapentin
- Oxcarbazepine
Other Study ID Numbers
- P00008001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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