Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Stopped early · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT01675960

Run by

Gillette Children's Specialty Healthcare

People needed

2

Starts

2012-04-01

Expected to finish

2017-07-01

Last updated by the study team

2019-08-02

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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