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Prevention of Post-Traumatic Seizures With Levetiracetam (TRACK)
This study is currently recruiting participants.
Study NCT00566046   Information provided by Rennes University Hospital
First Received: November 29, 2007   Last Updated: October 27, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

November 29, 2007
October 27, 2008
November 2007
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 ]
Same as current
Complete list of historical versions of study NCT00566046 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Prevention of Post-Traumatic Seizures With Levetiracetam
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

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.

 
Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Epilepsy, Post-Traumatic
  • Drug: Levetiracetam
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
600
December 2011
 

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)
Both
18 Years and older
No
Contact: Arnaud Biraben, MD arnaud.biraben@chu-rennes.fr
France
 
 
NCT00566046
Yves Rayer, Rennes University Hospital
LOC/06-06, CIC0203/60
Rennes University Hospital
UCB
Principal Investigator: Arnaud Biraben, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
Rennes University Hospital
October 2008

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