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Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Primary Purpose

Neurologically Impaired, Irritable Mood, Signs and Symptoms, Digestive

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gabapentin

placebo

About this trial

This is an interventional treatment trial for Neurologically Impaired focused on measuring chronic irritability, chronic pain, Neurologically impaired, gabapentin

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Gillette Children's Specialty Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Gabapentin, then placebo

Placebo, then Gabapentin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.

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.

Secondary Outcome Measures

Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin.

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.

Full Information

NCT ID

NCT01675960

First Posted

May 29, 2012

Last Updated

July 31, 2019

Sponsor

Gillette Children's Specialty Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT01675960

Brief Title

Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Terminated

Why Stopped

unable to enroll

Study Start Date

April 2012 (Actual)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gillette Children's Specialty Healthcare

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

chronic irritability, chronic pain, Neurologically impaired, gabapentin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gabapentin, then placebo

Arm Type

Experimental

Arm Description

Arm Title

Placebo, then Gabapentin

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Other Intervention Name(s)

Fanatrex, Neurontin, Gabarone, Gralise, Horizant

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.

Description

Time Frame

Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Secondary Outcome Measure Information:

Title

Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin.

Description

Time Frame

Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Schwantes, MD

Organizational Affiliation

Gillette Children's Specialty Healthcare

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gillette Children's Specialty Healthcare

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55101

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10863045

Citation

Perquin CW, Hazebroek-Kampschreur AAJM, Hunfeld JAM, Bohnen AM, van Suijlekom-Smit LWA, Passchier J, van der Wouden JC. Pain in children and adolescents: a common experience. Pain. 2000 Jul;87(1):51-58. doi: 10.1016/S0304-3959(00)00269-4.

Results Reference

background

PubMed Identifier

14662579

Citation

Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. doi: 10.1001/archpedi.157.12.1219.

Results Reference

background

PubMed Identifier

15132260

Citation

Houlihan CM, O'Donnell M, Conaway M, Stevenson RD. Bodily pain and health-related quality of life in children with cerebral palsy. Dev Med Child Neurol. 2004 May;46(5):305-10. doi: 10.1017/s0012162204000507.

Results Reference

background

PubMed Identifier

11719327

Citation

Stallard P, Williams L, Lenton S, Velleman R. Pain in cognitively impaired, non-communicating children. Arch Dis Child. 2001 Dec;85(6):460-2. doi: 10.1136/adc.85.6.460.

Results Reference

background

PubMed Identifier

16009254

Citation

Greco C, Berde C. Pain management for the hospitalized pediatric patient. Pediatr Clin North Am. 2005 Aug;52(4):995-1027, vii-viii. doi: 10.1016/j.pcl.2005.04.005.

Results Reference

background

PubMed Identifier

15174527

Citation

Breau LM, Camfield CS, McGrath PJ, Finley GA. Risk factors for pain in children with severe cognitive impairments. Dev Med Child Neurol. 2004 Jun;46(6):364-71. doi: 10.1017/s001216220400060x.

Results Reference

background

PubMed Identifier

12960651

Citation

Zangen T, Ciarla C, Zangen S, Di Lorenzo C, Flores AF, Cocjin J, Reddy SN, Rowhani A, Schwankovsky L, Hyman PE. Gastrointestinal motility and sensory abnormalities may contribute to food refusal in medically fragile toddlers. J Pediatr Gastroenterol Nutr. 2003 Sep;37(3):287-93. doi: 10.1097/00005176-200309000-00016.

Results Reference

background

PubMed Identifier

17272610

Citation

Hauer JM, Wical BS, Charnas L. Gabapentin successfully manages chronic unexplained irritability in children with severe neurologic impairment. Pediatrics. 2007 Feb;119(2):e519-22. doi: 10.1542/peds.2006-1609.

Results Reference

background

PubMed Identifier

11343050

Citation

Breau LM, Camfield C, McGrath PJ, Rosmus C, Finley GA. Measuring pain accurately in children with cognitive impairments: refinement of a caregiver scale. J Pediatr. 2001 May;138(5):721-7. doi: 10.1067/mpd.2001.112247.

Results Reference

background

PubMed Identifier

12237214

Citation

Breau LM, McGrath PJ, Camfield CS, Finley GA. Psychometric properties of the non-communicating children's pain checklist-revised. Pain. 2002 Sep;99(1-2):349-57. doi: 10.1016/s0304-3959(02)00179-3.

Results Reference

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Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

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