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

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.

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.

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.