A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children
Overview
- Phase
- Phase 2
- Intervention
- Gabapentin
- Conditions
- Neurologically Impaired
- Sponsor
- Gillette Children's Specialty Healthcare
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Gabapentin, then placebo
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.
Intervention: Gabapentin
Gabapentin, then placebo
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.
Intervention: placebo
Placebo, then Gabapentin
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: Gabapentin
Placebo, then Gabapentin
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: placebo
Outcomes
Primary Outcomes
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).
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 Outcomes
- Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin.(Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).)