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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219373
Recruitment Status : Not yet recruiting
First Posted : August 18, 2014
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Monique Ribeiro, Boston Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Pediatric Chronic Neuropathic Pain Drug: Gabapentin Drug: Oxcarbazepine Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Double-Blind, Randomized Clinical Effectiveness Study.
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin Drug: 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.

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

Experimental: Oxcarbazepine Drug: Oxcarbazepine
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.

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

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.
Drug: 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.

Drug: Oxcarbazepine
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.

Other: 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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Frequency of side effects- Tolerability [ Time Frame: 1, 2, 4, 6, 8 weeks (post assignment of intervention) ]
    • 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.


  3. Functional Disability Scores [ Time Frame: 0 (baseline), 4, and 8 weeks (post-assignment of intervention) ]
  4. 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.

  5. Frequency of Side Effects- Neuropsychological Measures [ Time Frame: Baseline, weeks 4 and 8 (post-assignment of the intervention). ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219373


Contacts
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Contact: Monique Ribeiro, MD (617) 355-7040 Monique.Ribeiro@childrens.harvard.edu
Contact: Kimberly Lobo, MPH (857) 218-3556 Kimberly.Lobo@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Principal Investigator: Monique Ribeiro, MD         
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Monique Ribeiro, MD Boston Children's Hospital
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Responsible Party: Monique Ribeiro, Physician, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02219373    
Other Study ID Numbers: P00008001
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Oxcarbazepine
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers