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| Descriptive Information Fields | |||||||||
| 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 | ||||||||
| Primary Outcome Measure † | 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 ] | ||||||||
| Secondary Outcome Measure † | 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 ] | ||||||||
| Condition † | Epilepsy, Post-Traumatic | ||||||||
| Intervention † | Drug: Levetiracetam Drug: Placebo |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 600 | ||||||||
| Start Date † | November 2007 | ||||||||
| Completion Date | December 2011 | ||||||||
| 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 | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00566046 | ||||||||
| Organization ID | EudraCT: 2006-006518-13 | ||||||||
| 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 | ||||||||
| First Received Date † | November 29, 2007 | ||||||||
| Last Updated Date | October 27, 2008 | ||||||||