Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gillette Children's Specialty Healthcare; Scott Schwantes, M.D.
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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.