Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01675960
• Other study ID #: 112909
• Status: Terminated
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: July 2017

Study information

• Verified date: July 2019
• Source: Gillette Children's Specialty Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Irritable Mood
• Neurologically Impaired
• Signs and Symptoms
• Signs and Symptoms, Digestive
• Sleep Initiation and Maintenance Disorders
• Sleeplessness

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Gillette Children's Specialty Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View Citation

Greco C, Berde C. Pain management for the hospitalized pediatric patient. Pediatr Clin North Am. 2005 Aug;52(4):995-1027, vii-viii. Review. — View 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. — View 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. — View Citation

Perquin CW, Hazebroek-Kampschreur AA, Hunfeld JA, Bohnen AM, van Suijlekom-Smit LW, Passchier J, van der Wouden JC. Pain in children and adolescents: a common experience. Pain. 2000 Jul;87(1):51-8. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).
Secondary	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.	Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).