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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 June 2015 |
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Main ID: |
NCT00376766 |
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Date of registration:
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14/09/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)
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Scientific title:
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Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures. |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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112 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00376766 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Serge CHASSAGNON, Dr |
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Address:
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Email:
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Affiliation:
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University Hospital of Strasbourg |
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Name:
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Helene CATENOIX, Dr |
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Address:
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Email:
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Affiliation:
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University Hospital of Lyon |
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Name:
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Pierre THOMAS, Dr |
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Address:
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Email:
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Affiliation:
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University Hospital of Nice |
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Name:
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Philippe CONVERS, Dr |
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Address:
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Email:
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Affiliation:
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University Hospital of St Etienne |
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Name:
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Louis Maillard, Dr |
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Address:
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Email:
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Affiliation:
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Central Hospital, Nancy, France |
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Name:
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William SZHURAJ, Dr |
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Address:
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Email:
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Affiliation:
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University Hospital of Lille |
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Name:
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Edouard HIRSH, Dr |
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Address:
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Email:
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Affiliation:
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University Hospital of Strasbourg |
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Name:
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Philippe DERAMBURE, Dr |
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Address:
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Email:
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Affiliation:
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University Hospital of Lille |
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Name:
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Dominique ROSENBERG, Dr |
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Address:
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Affiliation:
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University Hospital of Clermont-Ferrand |
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Name:
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Cecile SABOURY, Dr |
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Address:
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Email:
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Affiliation:
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University Hospital of Strasbourg |
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Name:
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Jerome PETIT, Dr |
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Address:
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Affiliation:
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La Teppe Institution |
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Name:
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Vincent TAREL, Dr |
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Address:
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Affiliation:
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Regional Hospital of Chambery |
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Name:
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Philippe RYVELIN, Dr |
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Address:
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Affiliation:
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University Hospital of Lyon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age from 18 to 65
- Drug resistant epilepsy, partial seizure
- Epilepsy diagnosed for more than 2 years
- Epilepsy treated for more than 1 year with no change of treatment in the month before
the enrolment
- Onset of cluster seizure in the 24 hours before enrolment
- For women : effective contraception
- Affiliation to the French social security
Exclusion Criteria:
- Inability to tolerate levetiracetam, likely poor compliance
- Patient taking antiepileptic treatment (benzodiazepine) in addition to current
treatment during the last 48h00.
- Patient taking 1g/day of levetiracetam with Creatinin clearance < 50ml/min
- Patient taking 2g/day of levetiracetam with Creatinin clearance < 80ml/min
- Patient taking more than 2g/day of levetiracetam
- Hepatic or cardiovascular pathology
- Progressive psychiatric pathology
- Degenerative neurologic disease
- Cluster seizure due to an acute symptomatic reason
- Disorder of consciousness
- Suspicion of status epilepticus or rapid evolution to status epilepticus
- Suspicion of psychogenic nonepileptic seizure
- Pregnant woman or nursing woman
- Suicidal thoughts
- Incapacity to give consent, minor patient
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Drug Resistant
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Epilepsy
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Intervention(s)
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Drug: levetiracetam
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Primary Outcome(s)
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Ratio of patients who are free of seizure between H3 and H24 in both groups.
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Secondary Outcome(s)
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Time between H0 and the last seizure.
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Items 1,2,3 of the Clinical Global Impression scale.
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Type and ratio of epileptic fit between H0 and H24.
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Side effects during the study.
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Number of seizures occured between H3 and H10, H10 and H17, H17 and H24, corresponding to the half-time of the treatment (7 hours).
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Description of therapeutic adaptation at 1 month after patient enrolment.
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Secondary ID(s)
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DTCIC 05 24
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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