Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT00376766
Status:
TERMINATED
Last Update Posted:
2015-05-28
First Post:
2006-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D000069279', 'term': 'Drug Resistant 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'whyStopped': 'recruitment recruitment recruitment recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2006-09-14', 'studyFirstSubmitQcDate': '2006-09-14', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of patients who are free of seizure between H3 and H24 in both groups.'}], 'secondaryOutcomes': [{'measure': 'Items 1,2,3 of the Clinical Global Impression scale.'}, {'measure': 'Side effects during the study.'}, {'measure': 'Time between H0 and the last seizure.'}, {'measure': 'Type and ratio of epileptic fit between H0 and H24.'}, {'measure': 'Number of seizures occured between H3 and H10, H10 and H17, H17 and H24, corresponding to the half-time of the treatment (7 hours).'}, {'measure': 'Description of therapeutic adaptation at 1 month after patient enrolment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cluster seizure', 'seizure clustering', 'repetitive seizure', 'Drug resistant epilepsy', 'Levetiracetam', 'keppra'], 'conditions': ['Epilepsy', 'Drug Resistant']}, 'referencesModule': {'references': [{'pmid': '15660781', 'type': 'BACKGROUND', 'citation': 'Haut SR, Shinnar S, Moshe SL. Seizure clustering: risks and outcomes. Epilepsia. 2005 Jan;46(1):146-9. doi: 10.1111/j.0013-9580.2005.29004.x.'}, {'pmid': '9637805', 'type': 'BACKGROUND', 'citation': 'Dreifuss FE, Rosman NP, Cloyd JC, Pellock JM, Kuzniecky RI, Lo WD, Matsuo F, Sharp GB, Conry JA, Bergen DC, Bell WE. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med. 1998 Jun 25;338(26):1869-75. doi: 10.1056/NEJM199806253382602.'}, {'pmid': '10565590', 'type': 'BACKGROUND', 'citation': 'Mitchell WG, Conry JA, Crumrine PK, Kriel RL, Cereghino JJ, Groves L, Rosenfeld WE. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group. Epilepsia. 1999 Nov;40(11):1610-7. doi: 10.1111/j.1528-1157.1999.tb02047.x.'}, {'pmid': '10999557', 'type': 'BACKGROUND', 'citation': 'Shorvon SD, Lowenthal A, Janz D, Bielen E, Loiseau P. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. European Levetiracetam Study Group. Epilepsia. 2000 Sep;41(9):1179-86. doi: 10.1111/j.1528-1157.2000.tb00323.x.'}, {'pmid': '10908898', 'type': 'BACKGROUND', 'citation': 'Cereghino JJ, Biton V, Abou-Khalil B, Dreifuss F, Gauer LJ, Leppik I. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology. 2000 Jul 25;55(2):236-42. doi: 10.1212/wnl.55.2.236.'}]}, 'descriptionModule': {'briefSummary': 'This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy and safety, in epilepsy cluster seizure.\n\nEfficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient has a seizure during this interval, he is considered as a non-respondent patient.', 'detailedDescription': 'Seizure clustering has been defined as a series of unusual frequency of seizures with return to baseline between events. The most common definition of cluster seizure is three seizures per 24 hours.\n\nThe usual treatment of cluster seizure is benzodiazepin. This is recognized efficient therapy but has many side effects. Thus it is important to develop as an new therapeutic to improve patient care. Levetiracetam is an antiepileptic drug used in addition to other antiepileptic drugs with less side effects than benzodiazepin.\n\nThe aim of this study is to evaluate the effectiveness and safety of levetiracetam in epilepsy cluster seizure.\n\nThis is a double blind, placebo controlled, add-on clinical trial with two phases :\n\nPhase 1 : Double blind phase during 24 hours (H0 to H24). After consent signature and randomization, the patient takes two tablets of levetiracetam or placebo. If the patient has a seizure between H3 and H24, he is considered as a non-respondent patient. If there is a risk of rapid evolution to an statue epilepticus, the investigator can break the blind and adapt the patient treatment accordingly.\n\nPhase 2 : This is an open phase after H24. this phase consists of breaking the blind with free adaption of the therapy by the investigator, and patients follow-up during 1 month.\n\nThe randomization is stratify by center. The size of randomization blocks is random because of the systematic breaking blind after 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 65\n* Drug resistant epilepsy, partial seizure\n* Epilepsy diagnosed for more than 2 years\n* Epilepsy treated for more than 1 year with no change of treatment in the month before the enrolment\n* Onset of cluster seizure in the 24 hours before enrolment\n* For women : effective contraception\n* Affiliation to the French social security\n\nExclusion Criteria:\n\n* Inability to tolerate levetiracetam, likely poor compliance\n* Patient taking antiepileptic treatment (benzodiazepine) in addition to current treatment during the last 48h00.\n* Patient taking 1g/day of levetiracetam with Creatinin clearance \\< 50ml/min\n* Patient taking 2g/day of levetiracetam with Creatinin clearance \\< 80ml/min\n* Patient taking more than 2g/day of levetiracetam\n* Hepatic or cardiovascular pathology\n* Progressive psychiatric pathology\n* Degenerative neurologic disease\n* Cluster seizure due to an acute symptomatic reason\n* Disorder of consciousness\n* Suspicion of status epilepticus or rapid evolution to status epilepticus\n* Suspicion of psychogenic nonepileptic seizure\n* Pregnant woman or nursing woman\n* Suicidal thoughts\n* Incapacity to give consent, minor patient'}, 'identificationModule': {'nctId': 'NCT00376766', 'briefTitle': 'Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.', 'orgStudyIdInfo': {'id': 'DTCIC 05 24'}}, 'armsInterventionsModule': {'interventions': [{'name': 'levetiracetam', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06002', 'city': 'Nice', 'state': 'Alpes de Haute provence', 'country': 'France', 'facility': 'Neurology department', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '26600', 'city': "Tain-l'Hermitage", 'state': 'Drome', 'country': 'France', 'facility': 'Etablissement la Teppe', 'geoPoint': {'lat': 45.06672, 'lon': 4.8559}}, {'zip': '3043', 'city': 'Grenoble', 'state': 'Isere', 'country': 'France', 'facility': 'Neurology department', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Neurology department', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '42055', 'city': 'Saint-Étienne-de-Montluc', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Neurology department', 'geoPoint': {'lat': 47.27622, 'lon': -1.78013}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'state': 'Puy de Dome', 'country': 'France', 'facility': 'Neurology department', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '69000', 'city': 'Lyon', 'state': 'Rhone', 'country': 'France', 'facility': 'Neurology department', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '73000', 'city': 'Chambéry', 'state': 'Savoie', 'country': 'France', 'facility': 'Neurology Department', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '54035', 'city': 'Nancy', 'country': 'France', 'facility': 'Neurology department', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Neurology department', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Louis Maillard, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}, {'name': 'Serge CHASSAGNON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Strasbourg'}, {'name': 'Cecile SABOURY, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Strasbourg'}, {'name': 'Edouard HIRSH, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Strasbourg'}, {'name': 'William SZHURAJ, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Lille'}, {'name': 'Philippe DERAMBURE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Lille'}, {'name': 'Jerome PETIT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Teppe Institution'}, {'name': 'Vincent TAREL, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional Hospital of Chambery'}, {'name': 'Dominique ROSENBERG, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}, {'name': 'Helene CATENOIX, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Lyon'}, {'name': 'Philippe RYVELIN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Lyon'}, {'name': 'Philippe CONVERS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of St Etienne'}, {'name': 'Pierre THOMAS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'UCB Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}