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Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01675960
Recruitment Status : Terminated (unable to enroll)
First Posted : August 30, 2012
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Gillette Children's Specialty Healthcare

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.

Condition or disease Intervention/treatment Phase
Neurologically Impaired Irritable Mood Signs and Symptoms, Digestive Sleeplessness Chronic Pain Drug: Gabapentin Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2012
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: 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.
Drug: Gabapentin
The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period.
Other Names:
  • Fanatrex
  • Neurontin
  • Gabarone
  • Gralise
  • Horizant

Drug: placebo
The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.

Experimental: 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.
Drug: Gabapentin
The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period.
Other Names:
  • Fanatrex
  • Neurontin
  • Gabarone
  • Gralise
  • Horizant

Drug: placebo
The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin. [ Time Frame: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study). ]
    We will attempt to identify gastrointestinal and sleep problems in neurologically impaired children with questionnaires given throughout the study. We hypothesize that gastrointestinal symptoms (feeding intolerance and symptoms associated with gas and bowel movements) and disrupted sleep are frequently associated with chronic irritability and will improve with gabapentin.



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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675960


Locations
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United States, Minnesota
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
Gillette Children's Specialty Healthcare
Investigators
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Principal Investigator: Scott Schwantes, MD Gillette Children's Specialty Healthcare
  Study Documents (Full-Text)

Documents provided by Gillette Children's Specialty Healthcare:
Study Protocol  [PDF] April 26, 2013
Statistical Analysis Plan  [PDF] April 26, 2013

Publications:

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Responsible Party: Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier: NCT01675960    
Other Study ID Numbers: 112909
First Posted: August 30, 2012    Key Record Dates
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gillette Children's Specialty Healthcare:
chronic irritability
chronic pain
Neurologically impaired
gabapentin
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Chronic Pain
Signs and Symptoms, Digestive
Pain
Neurologic Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents