Clinical trial NCT01675960: Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neurologically Impaired
Irritable Mood
Signs and Symptoms, Digestive
Sleeplessness
Chronic Pain
Keywords: chronic irritability
chronic pain
Neurologically impaired
gabapentin
Lead sponsor: Gillette Children's Specialty Healthcare
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.
timeFrame: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).
Secondary outcomes:
measure: Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin.
timeFrame: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: Gillette Children's Specialty Healthcare
name: Scott Schwantes, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zangen T, Ciarla C, Zangen S, Di Lorenzo C, Flores AF, Cocjin J, Reddy SN, Rowhani A, Schwankovsky L, Hyman PE. Gastrointestinal motility and sensory abnormalities may contribute to food refusal in medically fragile toddlers. J Pediatr Gastroenterol Nutr. 2003 Sep;37(3):287-93. doi: 10.1097/00005176-200309000-00016.
citation: Hauer JM, Wical BS, Charnas L. Gabapentin successfully manages chronic unexplained irritability in children with severe neurologic impairment. Pediatrics. 2007 Feb;119(2):e519-22. doi: 10.1542/peds.2006-1609.
citation: Breau LM, Camfield C, McGrath PJ, Rosmus C, Finley GA. Measuring pain accurately in children with cognitive impairments: refinement of a caregiver scale. J Pediatr. 2001 May;138(5):721-7. doi: 10.1067/mpd.2001.112247.
citation: Breau LM, McGrath PJ, Camfield CS, Finley GA. Psychometric properties of the non-communicating children's pain checklist-revised. Pain. 2002 Sep;99(1-2):349-57. doi: 10.1016/s0304-3959(02)00179-3.