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

NCT ID: NCT02219373

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-12-31

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.

Conditions

Pediatric Chronic Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gabapentin

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: 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

Intervention Type: OTHER

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

Oxcarbazepine

Group Type: EXPERIMENTAL

Oxcarbazepine

Intervention Type: 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

Intervention Type: OTHER

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Gabapentin

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Monique Ribeiro

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monique Ribeiro, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Monique Ribeiro, MD

Role: CONTACT

Monique.Ribeiro@childrens.harvard.edu

(617) 355-7040

Kimberly Lobo, MPH

Role: CONTACT

Kimberly.Lobo@childrens.harvard.edu

(857) 218-3556

Other Identifiers

P00008001

Identifier Type: -

Identifier Source: org_study_id