Suspended

A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children

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What is being tested

Gabapentin

+ placebo

+ Gabapentin

Drug
Who is being recruted

Mental Disorders+9

+ Nervous System Diseases

+ Neurologic Manifestations

From 1 Months to 16 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2012
See protocol details

Summary

Principal SponsorGillette Children's Specialty Healthcare
Last updated: August 2, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01675960
Principal SponsorGillette Children's Specialty Healthcare
Last updated: August 2, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 Months to 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersNervous System DiseasesNeurologic ManifestationsPainSigns and SymptomsSleep Wake DisordersPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Initiation and Maintenance DisordersSigns and Symptoms, DigestiveChronic Pain

Criteria

5 inclusion criteria required to participate
1 month to 16 years of age at enrollment
Subject must have an acceptable surrogate capable of giving consent on the subject's behalf
chronic irritability defined as symptoms suggesting pain to the child's caregiver recurrently over a 4-week of greater time period
male or female
Show More Criteria
5 exclusion criteria prevent from participating
Children with resolved symptoms after treatment of identified sources of pain
Current treatment with gabapentin or pregabalin for another existing condition
Identified potential source of irritability without adequate trial of appropriate management
Ketogenic diet
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Gillette Children's Specialty Healthcare

Saint Paul, United StatesOpen Gillette Children's Specialty Healthcare in Google Maps
SuspendedOne Study Center