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Prevention of Post-Traumatic Seizures With Levetiracetam (TRACK)

This study is currently recruiting participants.
Study NCT00566046.   Last updated on October 27, 2008.   Information provided by Rennes University Hospital

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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.

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
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  600
Start Date  November 2007
Completion Date December 2011
Eligibility Criteria 

Inclusion Criteria:

  1. Age >= 18 years old
  2. Patient with severe brain injury defined as follow:

    • Initial Glasgow Coma score (assessed on the scene of the accident) <= 8 related to the brain injury
    • Stage 2 to 4 on the TDM US TCDB classification
  3. Initial brain CT scan performed within 48 hours after hospital admission
  4. Either a male or a nonpregnant, non-lactating female who is using adequate contraceptive method (a urine laboratory pregnancy test must be negative at baseline)
  5. Written informed consent from the patient's next-of-kin. If no relative is present as the time of inclusion, the patients will be included according to the emergency procedure

Exclusion Criteria:

  1. Isolated extradural hematoma
  2. Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.)
  3. Current participation in an other protocol or within one month before study entry
  4. Previous treatment with Levetiracetam
  5. Patient's follow-up judged to be difficult by the investigator
  6. Known allergy to either Levetiracetam or products derived from pyrrolidone or one of its excipients
  7. Epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol)
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Arnaud Biraben, MD         arnaud.biraben@chu-rennes.fr    
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 
Principal Investigator:     Arnaud Biraben, MD     Rennes University Hospital    
Study Chair:     Bruno Laviolle, MD     Rennes University Hospital    
Information Provided By Rennes University Hospital
Verification Date October 2008
First Received Date  November 29, 2007
Last Updated Date October 27, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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