Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

July 31, 2019 updated by: Gillette Children's Specialty Healthcare

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Gillette Children's Specialty Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gabapentin, then placebo
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.
Drug: Gabapentin
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.
Other Names:
  • Gralise
  • Neurontin
  • Gabarone
  • Fanatrex
  • Horizant
Drug: placebo
The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.
Experimental: Placebo, then Gabapentin
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.
Drug: Gabapentin
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.
Other Names:
  • Gralise
  • Neurontin
  • Gabarone
  • Fanatrex
  • Horizant
Drug: placebo
The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
We will determine whether gabapentin provides symptom relief for chronic irritability in neurologically impaired children, who continue to have irritability even though potential sources may have been identified and treated, or have sources that have not been identified.
Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
We will attempt to identify gastrointestinal and sleep problems in neurologically impaired children with questionnaires given throughout the study. We hypothesize that gastrointestinal symptoms (feeding intolerance and symptoms associated with gas and bowel movements) and disrupted sleep are frequently associated with chronic irritability and will improve with gabapentin.
Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gillette Children's Specialty Healthcare

Investigators

  • Principal Investigator: Scott Schwantes, MD, Gillette Children's Specialty Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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