Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Insomnia Sleep Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any - 16 |
| Updated: | 4/21/2016 |
| Start Date: | April 2012 |
| End Date: | October 2020 |
A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children
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.
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.
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.
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.
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.
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