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Prevention of Post-Traumatic Seizures With Levetiracetam (TRACK)
This study is currently recruiting participants.
Verified by Rennes University Hospital, October 2008
Sponsors and Collaborators: Rennes University Hospital
UCB
Information provided by: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00566046
  Purpose

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.


Condition Intervention Phase
Epilepsy, Post-Traumatic
Drug: Levetiracetam
Drug: Placebo
Phase III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures Traumatic Brain Injury
Drug Information available for: Levetiracetam
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Rennes University Hospital:

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 ]

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 ]

Estimated Enrollment: 600
Study Start Date: November 2007
Estimated Study Completion Date: December 2011
Arms Assigned Interventions
Levetiracetam: Experimental Drug: Levetiracetam
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
Placebo: Placebo Comparator Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566046

Contacts
Contact: Arnaud Biraben, MD arnaud.biraben@chu-rennes.fr

Locations
France
Neurologie - CHU Rennes Recruiting
Rennes, France, 35000
Contact: Arnaud Biraben, MD         arnaud.biraben@chu-rennes.fr    
Sponsors and Collaborators
Rennes University Hospital
UCB
Investigators
Principal Investigator: Arnaud Biraben, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
  More Information

Responsible Party: Rennes University Hospital ( Yves Rayer )
Study ID Numbers: EudraCT: 2006-006518-13, LOC/06-06, CIC0203/60
Study First Received: November 29, 2007
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00566046  
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Craniocerebral Trauma
Epilepsy
Seizures
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Etiracetam
Trauma, Nervous System
Brain Diseases
Epilepsy, Post-Traumatic
Brain Injuries

Additional relevant MeSH terms:
Nootropic Agents
Therapeutic Uses
Nervous System Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009