Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Neurologically Impaired Irritable Mood Signs and Symptoms, Digestive Sleeplessness Chronic Pain |
| Intervention | Drug: Gabapentin Drug: placebo |
| Phase | Phase 2 |
| Sponsor | Scott Schwantes, M.D. |
| Responsible Party | Gillette Children's Specialty Healthcare |
| ClinicalTrials.gov Identifier | NCT01675960 |
| First Received | May 29, 2012 |
| Last Updated | October 24, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 29, 2012 |
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| Last Updated Date | October 24, 2013 |
| Start Date | April 2012 |
| Estimated Primary Completion Date | May 2015 |
| Current Primary Outcome Measures | 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).] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures | 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).] [Designated as safety issue: No]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. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children |
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| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
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| 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. Other Names:
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
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| Estimated Enrollment | 40 |
| Estimated Completion Date | May 2015 |
| Estimated Primary Completion Date | April 2015 |
| 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. |
| Gender | Both |
| Ages | 1 Month |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Kari A Williams, MPH, CCRC 651-325-2316 KariAWilliams@gillettechildrens.com |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01675960 |
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| Other Study ID Numbers | 112909 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Gillette Children's Specialty Healthcare |
| Study Sponsor | Scott Schwantes, M.D. |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Scott Schwantes, MD Gillette Children's Specialty Healthcare |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| Gillette Children's Specialty Healthcare | St. Paul, Minnesota, United States, 55101 Contact: Kari A Williams, MPH, CCRC | 651-325-2316 | KariAWilliams@gillettechildrens.comPrincipal Investigator: Scott Schwantes, MD Recruiting |
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