Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-01 @ 10:08 PM
Study NCT ID:
NCT01061866
Status:
COMPLETED
Last Update Posted:
2010-02-18
First Post:
2009-02-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thalidomide Low Threshold in Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsotelo@unam.mx', 'phone': '5255-5652-8285', 'title': 'Julio Sotelo', 'organization': 'National Institute of Neurology and Neurosurgery of Mexico'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'During the trial we observed two serious adverse events, one of them presented exacerbation of seizures, another patient showed sedation, at 3 and 7 months respectively to the beginning of treatment.\n\nOther adverse events consisted in sensory neuropathy in 2 out of 7 patients tested with nerve conduction studies.', 'eventGroups': [{'id': 'EG000', 'title': 'Thalidomide', 'description': 'Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.', 'otherNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'sensorial neuropathy', 'notes': 'Seven patients were in risk however two participant were affected with less adverse events consisted in sensory neuropathy tested with nerve conduction studies.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}], 'seriousEvents': [{'term': 'sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'seizures exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Mean Number of Daily Seizures at 1 Year.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thalidomide', 'description': 'Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.02', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.02', 'pValueComment': 'p-value is non-adjusted for multiple comparisons', 'estimateComment': 'The frequency of seizures at the beginning of the study and after treatment with thalidomide was contrasted in the same group patients.', 'groupDescription': 'Power=0.02', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Was adjusted the degrees of freedom for the averaged test of significance.', 'testedNonInferiority': True, 'nonInferiorityComment': 'p less than or equal to 0.05, repeated measures ANOVA'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 3 months and 1 year of treatment', 'unitOfMeasure': 'Number of Seizures', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'males of 25 years old mean with refractory epilepsy, antiepileptic treatment and electroencephalographic study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thalidomide', 'description': 'Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients with refractory epilepsy, 25 years old mean, with antiepileptic treatment and several seizures by month and male gender and they were recruited by Epilepsy Clinic', 'preAssignmentDetails': 'Males without seizures three months prior to thalidomide administration and patients without electroencephalographic study and without antiepileptic treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Thalidomide', 'description': 'Tablets thalidomide at 200 mg dosage 100 mg in the morning and 100 mg in the night was administered daily during a twelve month period.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-05', 'studyFirstSubmitDate': '2009-02-17', 'resultsFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-07', 'studyFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Mean Number of Daily Seizures at 1 Year.', 'timeFrame': 'Baseline 3 months and 1 year of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thalidomide', 'Antiepileptic drugs', 'Refractory epilepsy', 'Sedative drugs'], 'conditions': ['Refractory Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.', 'detailedDescription': "Seven male patients with chronic, refractory epilepsy were included in the present study; in all cases antiepileptic treatment with multiple antiepileptic drugs had been unsuccessful in reducing the frequency or the intensity of seizures. Patients selected for this study were all males due to the high risk of thalidomide for teratogenicity in pregnant women; besides this drawback, thalidomide presents a fair tolerance profile in humans treated with low doses. Informed consent was obtained on each case by the patient and his legal guardian. The protocol was approved by the committees of research and ethics.\n\nTreatment with thalidomide at 200 mg dosage twice daily was administered during a twelve month period. Electroencephalograms were obtained prior and at six months of thalidomide therapy; number and intensity of seizures were individually recorded in a diary by a caregiver (in most cases the patient's mother); signs of neuropathy, a frequent side-effect of chronic thalidomide therapy, were evaluated along the treatment; drowsiness and sedation, which are also common side-effects, were also recorded.\n\nPatients were seen once a week during the treatment period at the Epilepsy Clinic of the National Institute of Neurology and Neurosurgery of Mexico. Once informed consent was obtained, all patients were given seizure diaries to be filled for three months before starting the treatment with thalidomide. Comparisons in the frequency of seizures were made on each patient by contrasting the three months previous to the beginning of thalidomide therapy with the twelve months of the drug trial. One patient (case 6) withdrew from the trial after seven months of thalidomide therapy due to sedation. Another patient (case 7) withdrew from the trial after 3 months of treatment due to exacerbation of seizures as narrated by his mother.\n\nThe same schedule of antiepileptic therapy was taken by each patient during three months prior to thalidomide administration and continued it without modification along the trial; therefore, bias due to changes in the associated antiepileptic medications were prevented and each patient served as his own control; so that the effect of thalidomide on the frequency and intensity of seizures could be reasonably evaluated. Thalidomide was purchased by the National Institute of Neurology and Neurosurgery of Mexico at regular price in the pharmaceutical market. No pharmaceutical company participated in any form in this trial."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory Epilepsy, males\n\nExclusion Criteria:\n\n* Females, peripheric neuropathy'}, 'identificationModule': {'nctId': 'NCT01061866', 'briefTitle': 'Thalidomide Low Threshold in Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Neurology and Neurosurgery, Mexico'}, 'officialTitle': 'Treatment of Refractory Epilepsy With Thalidomide: an Open Trial', 'orgStudyIdInfo': {'id': 'INNN 36/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thalidomide', 'description': 'Open-labeled preliminary trial', 'interventionNames': ['Drug: 3-phthalimidoglutarimide (Thalidomide)']}], 'interventions': [{'name': '3-phthalimidoglutarimide (Thalidomide)', 'type': 'DRUG', 'otherNames': ['Talizer', '3-phthalimidoglutarimide'], 'description': 'Thalidomide at 200 mg dosage bid was administered during a twelve month period.', 'armGroupLabels': ['Thalidomide']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Julio Sotelo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Neurology and Neurosurgery of Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurology and Neurosurgery, Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Council of Science and Technology, Mexico', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Julio Sotelo, MD', 'oldOrganization': 'National Institute of Neurology and Neurosurgery, Mexico'}}}}