Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Gillette Children's

Status and phase: Terminated; Phase 2

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

Treatments: Drug: placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01675960

112909

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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2 participants in 2 patient groups

Gabapentin, then placebo

Experimental group

Description:

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.

Treatment:

Drug: Gabapentin

Drug: placebo

Placebo, then Gabapentin

Experimental group

Description:

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.

Treatment:

Drug: Gabapentin

Drug: placebo