Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Phase 2

Terminated

Conditions: Sleeplessness
Neurologically Impaired
Signs and Symptoms, Digestive
Irritable Mood
Chronic Pain

Brief Summary: 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.

Detailed Description: This is a randomized, placebo-controlled, cross-over study design of the effects of gabapentin on chronic irritability in neurologically impaired children. The study will involve a 22 day medication titration, followed by a 7 day stable dosing period and a 6 day medication taper period. After an additional 3 day washout period, the subject will cross-over to the remaining arm of the study. Subjects will be evaluated for symptoms of chronic pain. Since the subjects are generally non-communicative, the subjects will be evaluated by two questionnaires and the Non-Communicating Children's Pain Checklist-Revised, to be completed by their parent or primary caregiver.

The primary aim is to determine if gabapentin provides symptom relief for chronic irritability in neurologically impaired children.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Gabapentin, then placebo	Gabapentin	Participants first receive gabapentin 3 times per day, with varying dosing based on the protocol. After 34-38 days, a washout period of 3 days occurs, before then receiving the placebo dose for 32 days.
Gabapentin, then placebo	placebo	Participants first receive gabapentin 3 times per day, with varying dosing based on the protocol. After 34-38 days, a washout period of 3 days occurs, before then receiving the placebo dose for 32 days.
Placebo, then Gabapentin	Gabapentin	Participants first receive placebo 3 times per day. After 34-38 days, a washout period of 3 days occurs, before then receiving Gabapentin, with varying dosing based on the protocol, for 32 days.
Placebo, then Gabapentin	placebo	Participants first receive placebo 3 times per day. After 34-38 days, a washout period of 3 days occurs, before then receiving Gabapentin, with varying dosing based on the protocol, for 32 days.

Primary Outcome Measures

Name	Time	Method
Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.	Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).	We will determine whether gabapentin provides symptom relief for chronic irritability in neurologically impaired children, who continue to have irritability even though potential sources may have been identified and treated, or have sources that have not been identified.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin.	Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).	We will attempt to identify gastrointestinal and sleep problems in neurologically impaired children with questionnaires given throughout the study. We hypothesize that gastrointestinal symptoms (feeding intolerance and symptoms associated with gas and bowel movements) and disrupted sleep are frequently associated with chronic irritability and will improve with gabapentin.