Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00329732
Status:
TERMINATED
Last Update Posted:
2015-05-06
First Post:
2006-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kathleen.Bradley@jefferson.edu', 'phone': '215-955-2025', 'title': 'Kathleen Bradley', 'organization': 'Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine/Bupivicaine', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline (Placebo)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine/Bupivicaine'}], 'timeFrame': '30 minutes', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis was done. Study was terminated.'}, {'type': 'SECONDARY', 'title': 'Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;', 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'unitOfMeasure': 'participants', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.', 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'unitOfMeasure': 'participants', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;', 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'unitOfMeasure': 'participant', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine/Bupivicaine'}, {'id': 'FG001', 'title': 'Saline (Placebo)'}], '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': 'Lidocaine/Bupivicaine'}, {'id': 'BG001', 'title': 'Saline (Placebo)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Study terminated due to inadequate recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-16', 'studyFirstSubmitDate': '2006-05-24', 'resultsFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2006-05-24', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-24', 'studyFirstPostDateStruct': {'date': '2006-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;', 'timeFrame': '30 minutes'}, {'measure': 'Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.', 'timeFrame': '30 minutes'}, {'measure': 'Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;', 'timeFrame': '30 minutes'}]}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician.\n\n40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects, male or female, between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling IHS criteria for episodic migraine\n* Presenting to clinic in migraine status, meaning the migraine has continued for greater than or equal to 3 days but less than 3 months.\n* Pain must be reported as at least moderate pain level at time of injections\n\nExclusion Criteria:\n\nA subject is ineligible to participate in this study if he/she satisfies any of the following criteria:\n\n* Subjects who have received greater occipital nerve blocks in the past\n* Subjects who in their own or the investigator's opinion are unable to describe their symptoms\n* Subjects who are pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT00329732', 'briefTitle': 'Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status', 'orgStudyIdInfo': {'id': 'GON-DBPC/WBY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine/Bupivicaine', 'interventionNames': ['Drug: 0.5% bupivicaine and 2% lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'matching volume of saline injected', 'interventionNames': ['Drug: Saline placebo']}], 'interventions': [{'name': '0.5% bupivicaine and 2% lidocaine', 'type': 'DRUG', 'description': 'The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache', 'armGroupLabels': ['Lidocaine/Bupivicaine']}, {'name': 'Saline placebo', 'type': 'DRUG', 'description': 'matching volume of saline (placebo)', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Headache Center/Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'William B Young, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jefferson Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bruce Smith', 'oldOrganization': 'Thomas Jefferson University'}}}}