Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-06 @ 5:12 AM
Study NCT ID:
NCT00630968
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2008-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1541}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-14', 'studyFirstSubmitDate': '2008-02-27', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage reduction in seizure frequency.', 'timeFrame': '16-week treatment period'}], 'secondaryOutcomes': [{'measure': 'To further assess safety.'}, {'measure': 'The patient-weighted Quality Of Life In Epilepsy inventory.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Levetiracetam', 'Keppra'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '17681453', 'type': 'RESULT', 'citation': 'Steinhoff BJ, Somerville ER, Van Paesschen W, Ryvlin P, Schelstraete I. The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy. Epilepsy Res. 2007 Aug;76(1):6-14. doi: 10.1016/j.eplepsyres.2007.06.002. Epub 2007 Aug 6.'}, {'pmid': '17851135', 'type': 'RESULT', 'citation': 'Somerville ER, McLaughlin DB, Robinson MK, Berkovic SF. Adjunctive therapy of uncontrolled partial seizures with levetiracetam in Australian patients. Epilepsy Behav. 2007 Nov;11(3):338-42. doi: 10.1016/j.yebeh.2007.06.005. Epub 2007 Sep 11.'}, {'pmid': '16674605', 'type': 'RESULT', 'citation': 'Genton P, Sadzot B, Fejerman N, Peltola J, Despland PA, Steinhoff B, Rektor I, Wroe S, Maubrey MC, Vandervelden C, van Hammee G, Schlit AF, van Paesschen W. Levetiracetam in a broad population of patients with refractory epilepsy: interim results of the international SKATE trial. Acta Neurol Scand. 2006 Jun;113(6):387-94. doi: 10.1111/j.1600-0404.2006.00647.x.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Partial onset seizures, whether or not secondarily generalized;\n* at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;\n* using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.\n\nExclusion Criteria:\n\n* Presence of known pseudoseizures within the last year;\n* presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;\n* on felbamate with less than 18 months exposure;\n* on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;\n* uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.'}, 'identificationModule': {'nctId': 'NCT00630968', 'briefTitle': 'S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy', 'orgStudyIdInfo': {'id': 'N01031'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Levetiracetam (Keppra)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'UCB'}}}}