Overview

This trial is active, not recruiting.

Conditions neurologically impaired, irritable mood, signs and symptoms, digestive, sleeplessness, chronic pain
Treatments gabapentin, placebo
Phase phase 2
Sponsor Scott Schwantes, M.D.
Start date April 2012
End date October 2019
Trial size 40 participants
Trial identifier NCT01675960, 112909

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Neurotin
gabapentin Fanatrex
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.
(Placebo Comparator)
Glycerin based clear solution that is flavored similar to the commercial product
placebo

Primary Outcomes

Measure
Symptom relief for chronic irritability in neurologically impaired children using gabapentin.
time frame: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Secondary Outcomes

Measure
Prevalence of associated gastrointestinal and sleep problems in neurologically impaired children and improvement using gabapentin.
time frame: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Eligibility Criteria

Male or female participants from 1 month up to 16 years old.

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.

Additional Information

Official title A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children
Principal investigator Scott Schwantes, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Gillette Children's Specialty Healthcare.