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Neurologically Impaired | Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Neurologically Impaired research study

What is the primary objective of this study?

This study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.

Who is eligible to participate?

Inclusion Criteria: - male or female - 1 month to 16 years of age at enrollment - neurological impairment defined as subnormal (-2 S.D.) motor and/or cognitive ability from a variety of etiologies - chronic irritability defined as symptoms suggesting pain to the child's caregiver recurrently over a 4-week of greater time period - Subject must have an acceptable surrogate capable of giving consent on the subject's behalf Exclusion Criteria: - Children with resolved symptoms after treatment of identified sources of pain - Identified potential source of irritability without adequate trial of appropriate management - Ketogenic diet - Renal insufficiency or failure - Current treatment with gabapentin or pregabalin for another existing condition.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Neurologically Impaired

Irritable Mood

Signs and Symptoms, Digestive

Sleeplessness

Chronic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:GabapentinThe active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period.

Drug:placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

gabapentinNeurotin

placeboGlycerin based clear solution that is flavored similar to the commercial product

Study Status

Active, not recruiting

Start Date: April 2012

Completed Date: October 2020

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Symptom relief for chronic irritability in neurologically impaired children using gabapentin.

Secondary Outcome: Prevalence of associated gastrointestinal and sleep problems in neurologically impaired children and improvement using gabapentin.

Study sponsors, principal investigator, and references

Principal Investigator: Scott Schwantes, MD

Lead Sponsor: Scott Schwantes, M.D.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01675960

Perquin CW, Hazebroek-Kampschreur AA, Hunfeld JA, Bohnen AM, van Suijlekom-Smit LW, Passchier J, van der Wouden JC. Pain in children and adolescents: a common experience. Pain. 2000 Jul;87(1):51-8.

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