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Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

NCT01675960 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-08-02

Study results available
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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.

Conditions

  • Neurologically Impaired
  • Irritable Mood
  • Signs and Symptoms, Digestive
  • Sleeplessness
  • Chronic Pain

Interventions

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.

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.

Sponsors & Collaborators

  • Gillette Children's Specialty Healthcare

    lead OTHER

Principal Investigators

  • Scott Schwantes, MD · Gillette Children's Specialty Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675960 on ClinicalTrials.gov