Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT01675960
Status:
TERMINATED
Last Update Posted:
2019-08-02
First Post:
2012-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sschwantes@gillettechildrens.com', 'phone': '(612)813-7888', 'title': 'Scott Schwantes', 'organization': "Children's of Minnesota"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during each contact with the subject after initial drug administration. Patient contacts were scheduled at day 6, 13, 24, 28, 34-37, 38, 44, 51, 62, and 76. SAE still ongoing at end of study period will be followed up on to determine final outcome.', 'description': 'Adverse events are collection on all participants who received at least one dose of intervention, regardless of arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Gabapentin', 'description': 'Neurotin\n\nGabapentin: 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.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Glycerin based clear solution that is flavored similar to the commercial product\n\nplacebo', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Neurotin\n\nGabapentin: 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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Glycerin based clear solution that is flavored similar to the commercial product\n\nplacebo'}], 'timeFrame': 'Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'No one was ever enrolled in the placebo arm. The data was never analyzed for this secondary outcome. PI has left the organization therefore analysis will not occur.'}, {'type': 'SECONDARY', 'title': 'Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'Neurotin\n\nGabapentin: 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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Glycerin based clear solution that is flavored similar to the commercial product\n\nplacebo'}], 'timeFrame': 'Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'No one was ever enrolled in the placebo arm. The data was never analyzed for this secondary outcome. PI has left the organization therefore analysis will not occur.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gabapentin, Then Placebo', 'description': '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.'}, {'id': 'FG001', 'title': 'Placebo, Then Gabapentin', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gabapentin, Then Placebo', 'description': '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.'}, {'id': 'BG001', 'title': 'Placebo, Then Gabapentin', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There was no one enrolled on Placebo'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-04-26', 'size': 468897, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-09T12:52', 'hasProtocol': True}, {'date': '2013-04-26', 'size': 468897, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-09T12:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'unable to enroll', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2012-05-29', 'resultsFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-31', 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'description': '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.'}], 'secondaryOutcomes': [{'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).', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic irritability', 'chronic pain', 'Neurologically impaired', 'gabapentin'], 'conditions': ['Neurologically Impaired', 'Irritable Mood', 'Signs and Symptoms, Digestive', 'Sleeplessness', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '10863045', 'type': 'BACKGROUND', 'citation': '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': '14662579', 'type': 'BACKGROUND', 'citation': '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': '15132260', 'type': 'BACKGROUND', 'citation': "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': '11719327', 'type': 'BACKGROUND', 'citation': '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': '16009254', 'type': 'BACKGROUND', 'citation': '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': '15174527', 'type': 'BACKGROUND', 'citation': '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': '12960651', 'type': 'BACKGROUND', '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.'}, {'pmid': '17272610', 'type': 'BACKGROUND', '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.'}, {'pmid': '11343050', 'type': 'BACKGROUND', '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.'}, {'pmid': '12237214', 'type': 'BACKGROUND', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe primary aim is to determine if gabapentin provides symptom relief for chronic irritability in neurologically impaired children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female\n* 1 month to 16 years of age at enrollment\n* neurological impairment defined as subnormal (-2 S.D.) motor and/or cognitive ability from a variety of etiologies\n* chronic irritability defined as symptoms suggesting pain to the child's caregiver recurrently over a 4-week of greater time period\n* Subject must have an acceptable surrogate capable of giving consent on the subject's behalf\n\nExclusion Criteria:\n\n* Children with resolved symptoms after treatment of identified sources of pain\n* Identified potential source of irritability without adequate trial of appropriate management\n* Ketogenic diet\n* Renal insufficiency or failure\n* Current treatment with gabapentin or pregabalin for another existing condition."}, 'identificationModule': {'nctId': 'NCT01675960', 'briefTitle': 'Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children', 'organization': {'class': 'OTHER', 'fullName': "Gillette Children's Specialty Healthcare"}, 'officialTitle': 'A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children', 'orgStudyIdInfo': {'id': '112909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin, then placebo', 'description': '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.', 'interventionNames': ['Drug: Gabapentin', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, then Gabapentin', 'description': '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.', 'interventionNames': ['Drug: Gabapentin', 'Drug: placebo']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Fanatrex', 'Neurontin', 'Gabarone', 'Gralise', 'Horizant'], 'description': '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.', 'armGroupLabels': ['Gabapentin, then placebo', 'Placebo, then Gabapentin']}, {'name': 'placebo', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Gabapentin, then placebo', 'Placebo, then Gabapentin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "Gillette Children's Specialty Healthcare", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Scott Schwantes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Gillette Children's Specialty Healthcare"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gillette Children's Specialty Healthcare", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}