Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children

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

Intervention / Treatment
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* Drug: Gabapentin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin, then placebo<br>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. | Drug: Gabapentin<br>* The 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.<br>* Other names: Horizant;Drug: placebo<br>* The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.<br>|
| Experimental: Placebo, then Gabapentin<br>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. | Drug: Gabapentin<br>* The 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.<br>* Other names: Horizant;Drug: placebo<br>* The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin. | 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. | Compiled data reviewed at completion or withdrawal from study (3 months from beginning study). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin. | 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. | Compiled data reviewed at completion or withdrawal from study (3 months from beginning study). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic irritability, chronic pain, Neurologically impaired, gabapentin