A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Gabapentin (Drug)
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.
干预措施: placebo (Drug)
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.
干预措施: Gabapentin (Drug)
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.
干预措施: placebo (Drug)
结局指标
主要结局
Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.
时间窗: 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.
次要结局
- 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).)