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Tracking Information | |||||||||
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First Received Date † | November 29, 2007 | ||||||||
Last Updated Date | October 27, 2008 | ||||||||
Start Date † | November 2007 | ||||||||
Current Primary Outcome Measures † |
Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00566046 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
Rate of early seizures and of late epilepsy; treatment effects according to the patient's severity, the TDM US Traumatic Coma Data Bank, and the number of regions traumatized; global prognosis (Glasgow Outcome Scale); safety of Levetiracetam [ Time Frame: One year ] [ Designated as safety issue: Yes ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Prevention of Post-Traumatic Seizures With Levetiracetam | ||||||||
Official Title † | Prospective, Randomized, Double-Blind Study Assessing the Effects of Levetiracetam Compared to Placebo in the Prevention of Early Epileptic Seizures and Late Epilepsy in Patients With Severe Traumatic Brain Injury | ||||||||
Brief Summary | Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy. |
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Detailed Description | |||||||||
Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
Condition † | Epilepsy, Post-Traumatic | ||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 600 | ||||||||
Estimated Completion Date | December 2011 | ||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | France | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00566046 | ||||||||
Responsible Party | Yves Rayer, Rennes University Hospital | ||||||||
Secondary IDs †† | LOC/06-06, CIC0203/60 | ||||||||
Study Sponsor † | Rennes University Hospital | ||||||||
Collaborators †† | UCB | ||||||||
Investigators † |
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Information Provided By | Rennes University Hospital | ||||||||
Verification Date | October 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |