Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
TerminatedPhase 2NCT01675960
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Neurologically Impaired
- Irritable Mood
- Signs and Symptoms, Digestive
- Sleeplessness
- Chronic Pain
- Interventions
- Sponsor
- Gillette Children's Specialty Healthcare
- Start date
- 2012-04
- Primary completion
- 2017-07
- Sex
- All
- Age range
- from 1 Month to 16 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01675960