Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02219373 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusWithdrawn
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Stopped Withdrawn before enrolling Sponsor's reason: Study was withdrawn for feasibility-related concerns. Show 5 more changesShow less
    • Lead sponsor: Boston Children's Hospital to Boston Children's Hospital
    • Enrollment target: estimated 60 to confirmed 0
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised
  2. Notable Primary completion date: Dec 2025 to Dec 2028
    • Start date: Oct 2024 to Jun 2026
    • Study completion date: Dec 2026 to Dec 2028
    v9
  3. Notable Start date: Aug 2023 to Oct 2024v8
  4. Notable Primary completion date: Dec 2023 to Dec 2025
    • Start date: Oct 2022 to Aug 2023
    • Study completion date: Dec 2024 to Dec 2026
    v7
  5. Notable Primary completion date: Dec 2022 to Dec 2023
    • Start date: Sep 2021 to Oct 2022
    • Study completion date: Dec 2023 to Dec 2024
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Primary completion date: Dec 2021 to Dec 2022
    • Start date: Aug 2020 to Sep 2021
    • Study completion date: Dec 2022 to Dec 2023
    v5
  2. Notable Start date: Jun 2019 to Aug 2020v4
  3. Notable Start date: Jan 2019 to Jun 2019v3
  4. Notable Phase: Not applicable to Phase 3
    • Primary completion date: Oct 2016 to Dec 2021
    • Start date: Oct 2014 to Jan 2019
    • Study completion date: Oct 2016 to Dec 2022
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02219373
Lead Sponsor Boston Children's Hospital
Conditions
(from sponsor)
Pediatric Chronic Neuropathic Pain
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov