Title
Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children
Phase
Phase 2Lead Sponsor
Gillette Children's Specialty HealthcareStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Neurologically Impaired Irritable Mood Signs and Symptoms, Digestive Sleeplessness Chronic PainIntervention/Treatment
gabapentin ...Study Participants
2This 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.
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.
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.
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.
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.
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.
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.
| Event Type | Organ System | Event Term | Gabapentin | Placebo |
|---|
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.
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.
