Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

NCT01675960 | Terminated Phase 2 Results DMC

• 1 other identifier: 112909
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologically Impaired; Irritable Mood; Signs and Symptoms, Digestive; Sleeplessness; Chronic Pain

Keywords

chronic irritability; chronic pain; Neurologically impaired; gabapentin

Outcome Measures

Primary Outcomes (1)

• Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.

  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.

  Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Secondary Outcomes (1)

• 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).

Study Arms (2)

Gabapentin, then placebo

EXPERIMENTAL

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; Drug: placebo

Placebo, then Gabapentin

EXPERIMENTAL

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; Drug: placebo

Interventions

Gabapentin DRUG

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.

Also known as: Fanatrex, Neurontin, Gabarone, Gralise, Horizant

Gabapentin, then placebo; Placebo, then Gabapentin

placebo DRUG

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.

Gabapentin, then placebo; Placebo, then Gabapentin

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• male or female
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (10)

• Perquin CW, Hazebroek-Kampschreur AAJM, Hunfeld JAM, Bohnen AM, van Suijlekom-Smit LWA, Passchier J, van der Wouden JC. Pain in children and adolescents: a common experience. Pain. 2000 Jul;87(1):51-58. doi: 10.1016/S0304-3959(00)00269-4.

  PMID: 10863045 BACKGROUND

• Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. doi: 10.1001/archpedi.157.12.1219.

  PMID: 14662579 BACKGROUND

• Houlihan CM, O'Donnell M, Conaway M, Stevenson RD. Bodily pain and health-related quality of life in children with cerebral palsy. Dev Med Child Neurol. 2004 May;46(5):305-10. doi: 10.1017/s0012162204000507.

  PMID: 15132260 BACKGROUND

• Stallard P, Williams L, Lenton S, Velleman R. Pain in cognitively impaired, non-communicating children. Arch Dis Child. 2001 Dec;85(6):460-2. doi: 10.1136/adc.85.6.460.

  PMID: 11719327 BACKGROUND

• Greco C, Berde C. Pain management for the hospitalized pediatric patient. Pediatr Clin North Am. 2005 Aug;52(4):995-1027, vii-viii. doi: 10.1016/j.pcl.2005.04.005.

  PMID: 16009254 BACKGROUND

• Breau LM, Camfield CS, McGrath PJ, Finley GA. Risk factors for pain in children with severe cognitive impairments. Dev Med Child Neurol. 2004 Jun;46(6):364-71. doi: 10.1017/s001216220400060x.

  PMID: 15174527 BACKGROUND

• 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.

  PMID: 12960651 BACKGROUND

• 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.

  PMID: 17272610 BACKGROUND

• 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.

  PMID: 11343050 BACKGROUND

• 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.

  PMID: 12237214 BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms, Digestive; Sleep Initiation and Maintenance Disorders; Chronic Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Scott Schwantes
• Organization: Children's of Minnesota

sschwantes@gillettechildrens.com

(612)813-7888

Study Officials

• Scott Schwantes, MD

  Gillette Children's Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: August 30, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)