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Prevention of Post-Traumatic Seizures With Levetiracetam (TRACK)

This study is currently recruiting participants.
Verified by Rennes University Hospital, December 2007

Sponsors and Collaborators: Rennes University Hospital
UCB
Information provided by: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00566046
  Purpose

Post traumatic seizures can appear in frequently after a severe traumatic brain injury. Two sorts 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 treatments have 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
Phase III

Genetics Home Reference related topics:   pyridoxal 5'-phosphate-dependent epilepsy   

MedlinePlus related topics:   Epilepsy    Head and Brain Injuries    Seizures   

ChemIDplus related topics:   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 one 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: Levetiracetam
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months

  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 non pregnant, 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…)
  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 derivated products from pyrrilidone or one of 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
First Received:   November 29, 2007
Last Updated:   December 5, 2007
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 September 05, 2008




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