Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT04256603
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2020-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI
Sponsor:
Organization:
Raw JSON
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All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Gabapentin Group', 'description': 'The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neuropathic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records.'}, {'id': 'OG001', 'title': 'No Gabapentin Group', 'description': 'The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '18.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'wilcox two sample test', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Through completion of the study, up to 4 weeks after injury.', 'description': 'To determine if the time from injury influences the prevalence of neuropathic pain in acute SCI. Average of the pain during the previous 7 days on self-identified nerve or neuropathic pain levels (0-10) on 5 different measurements at the time of discharge on the Neuropathic Pain Scale. 0 being best (no pain)- 10 being worst pain. Total score range from 0 to 50.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '21 subjects were enrolled in the group treated with gabapentin, vs 6 in then no gabapentin'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gabapentin Group', 'description': 'The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin prior to admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records.'}, {'id': 'FG001', 'title': 'No Gabapentin Group', 'description': 'The arm included subjects who met all inclusion criteria, those with acute spinal cord injury admitted to acute care hospital and were approved and admitted to inpatient rehabilitation unit. All subjects in this group were started on Gabapentin during inpatient rehabilitation admission and continued during care. All subjects were screened with questionnaires with data collection based on electronic medical records. g care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gabapentin', 'description': 'Gabapentin prior to admission\n\nGabapentin: Timing of gabapentin initiation'}, {'id': 'BG001', 'title': 'No Gabapentin', 'description': 'Gabapentin during admission\n\nGabapentin: Timing of gabapentin initiation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-04', 'size': 279115, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_002.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-08-21T08:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2020-02-01', 'resultsFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-11', 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropathic Pain', 'timeFrame': 'Through completion of the study, up to 4 weeks after injury.', 'description': 'To determine if the time from injury influences the prevalence of neuropathic pain in acute SCI. Average of the pain during the previous 7 days on self-identified nerve or neuropathic pain levels (0-10) on 5 different measurements at the time of discharge on the Neuropathic Pain Scale. 0 being best (no pain)- 10 being worst pain. Total score range from 0 to 50.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuropathic pain', 'spinal cord injury'], 'conditions': ['Spinal Cord Injuries', 'Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a significant negative effect on quality of life. Efficacy of various treatments, however, remains controversial. There is evidence to support that gabapentin and pregabalin have some benefit in reducing neuropathic pain. Gabapentin is effective in the management of symptoms and concerns related to SCI including motor recovery, spasticity, and mood among others. This makes gabapentin an important pharmacologic intervention, which compels providers to define treatment guidelines related to its use. One aspect of which should relate to the timing of initiation of therapy. The goal of this study is to determine whether timing of initiation of treatment with gabapentin will decrease prevalence and intensity of neuropathic pain.', 'detailedDescription': "Neuropathic pain is a common complaint in those with spinal cord injury (SCI) that has a significant negative effect on quality of life. This makes the treatment of neuropathic pain a priority in the SCI population. Efficacy of various treatments, however, remains controversial. There is evidence to support that gabapentin and pregabalin have some benefit in reducing neuropathic pain. Other positive effects of gabapentin on those with SCI have also been demonstrated. However, there has not been a study on the influence of timing of initiation of gabapentin on the efficacy of using it to treat neuropathic pain in the SCI population. Such a finding could change the standard of care in treatment of acute SCI.\n\nThe pooled prevalence of neuropathic pain post spinal cord injury is 53%. Not only common, neuropathic pain is pervasive, affecting aspects of patients' lives including sleep, physical function, and mood that in turn impact their activities- work and recreational alike. Thus, neuropathic pain management contributes to quality of life for a majority of people with SCI.\n\nAlthough a high priority, the treatment of neuropathic pain in SCI remains notoriously difficult. Treatments options may be divided into pharmacologic and non-pharmacologic. Pharmacologic agents studied include amitriptyline, gabapentin, pregabalin, opiates, lidocaine, ketamine, valproate, lamotrigine, levetiracetam and carbamazepine; the most studied of which are amitriptyline, gabapentin, and pregabalin.\n\nGabapentin's potential is not limited to neuropathic pain management, making it a particularly compelling treatment option in the population with acute SCI. Gabapentin leads to improvement in total motor scores, reduced spasticity, reduced autonomic dysreflexia, and improved mood. Animal models suggest it may be neuroprotective in the acute phase of injury. In those who undergo spine surgery, regardless of presence of SCI, gabapentin given perioperatively leads to reduced opiate use and decreased pain in post-operative period. Additionally, when compared to narcotic alternatives, gabapentin has minimal side effects.\n\nNeuropathic pain in SCI is common, impactful, and difficult to treat. Gabapentin is effective in the management of symptoms and concerns related to SCI including motor recovery, spasticity, and mood among others. This makes gabapentin an important pharmacologic intervention, which compels providers to define treatment guidelines related to its use. One aspect of which should relate to the timing of initiation of therapy. The goal of this study is to determine whether early initiation of treatment with gabapentin will decrease average pain scores and opiate use when comparted to late initiation of treatment with gabapentin in the population with acute SCI. Gabapentin, although used commonly, is not started in all patients with acute SCI but is often started at the onset of neuropathic pain. If gabapentin is found to be more effective when initiated early, it would be reasonable to start gabapentin immediately following acute SCI in all patients in whom it is not otherwise contraindicated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of acute spinal cord injury\n2. Admission to acute inpatient rehabilitation\n\nExclusion Criteria:\n\n1. Unable to communicate verbally or by writing, unable to follow basic instructions, or unable to answer questions regarding their symptoms'}, 'identificationModule': {'nctId': 'NCT04256603', 'briefTitle': 'Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in SCI', 'organization': {'class': 'OTHER', 'fullName': 'MetroHealth Medical Center'}, 'officialTitle': 'Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in Spinal Cord Injury (SCI)', 'orgStudyIdInfo': {'id': 'IRB19-00117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Gabapentin early', 'description': 'Gabapentin prior to admission', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'OTHER', 'label': 'Gabapentin late', 'description': 'Gabapentin during admission', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'OTHER', 'label': 'No gabapentin', 'description': 'No gabapentin', 'interventionNames': ['Other: No gabapentin']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'description': 'Timing of gabapentin initiation', 'armGroupLabels': ['Gabapentin early', 'Gabapentin late']}, {'name': 'No gabapentin', 'type': 'OTHER', 'description': 'No gabapentin', 'armGroupLabels': ['No gabapentin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'C Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metro Health, Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MetroHealth Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Chong Kim', 'investigatorAffiliation': 'MetroHealth Medical Center'}}}}