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Prevention of Post-traumatic Seizures With Levetiracetam (TRACK)

Primary Purpose

Epilepsy, Post-Traumatic

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Levetiracetam
Placebo
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epilepsy, Post-Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Neurologie - CHU Angers
  • Neurology - CHU Bordeaux
  • Neurologie - CHU Caen
  • Neurochirurgie-CHU Grenoble
  • Neurology - CHU Rennes
  • Neurophysiologie Clinique - CHU Lille
  • Neurophysiologie clinique - CHU Lyon (Hôpital neurologique)
  • Beurophysiologie clinique - CHU Marseille
  • Epileptologie - CHU Montpellier
  • Neurologie - CHU Nancy
  • Neurochirurgie-Paris Saint Anne
  • Neurologie - CHU Rennes
  • Explorations Fonctionnelles Neurologiques - CHU Nantes
  • Neurologie - CHU Rouen
  • Neurologie - CHU Tours Hopital Trousseau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levetiracetam

Placebo

Arm Description

Outcomes

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

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; safety of Levetiracetam
Global prognosis (Glasgow Outcome Scale)

Full Information

First Posted
November 29, 2007
Last Updated
June 20, 2012
Sponsor
Rennes University Hospital
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00566046
Brief Title
Prevention of Post-traumatic Seizures With Levetiracetam
Acronym
TRACK
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision because of to small enrollment
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Post-Traumatic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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; safety of Levetiracetam
Time Frame
One year
Title
Global prognosis (Glasgow Outcome Scale)
Time Frame
3 months, 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years old 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 Initial brain CT scan performed within 48 hours after hospital admission 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) 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: Isolated extradural hematoma Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.) Current participation in an other protocol or within one month before study entry Previous treatment with Levetiracetam Patient's follow-up judged to be difficult by the investigator Known allergy to either Levetiracetam or products derived from pyrrolidone or one of its excipients Epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Biraben, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Laviolle, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Neurologie - CHU Angers
City
Angers
Country
France
Facility Name
Neurology - CHU Bordeaux
City
Bordeaux
Country
France
Facility Name
Neurologie - CHU Caen
City
Caen
Country
France
Facility Name
Neurochirurgie-CHU Grenoble
City
Grenoble
Country
France
Facility Name
Neurology - CHU Rennes
City
Grenoble
Country
France
Facility Name
Neurophysiologie Clinique - CHU Lille
City
Lille
Country
France
Facility Name
Neurophysiologie clinique - CHU Lyon (Hôpital neurologique)
City
Lyon
Country
France
Facility Name
Beurophysiologie clinique - CHU Marseille
City
Marseille
Country
France
Facility Name
Epileptologie - CHU Montpellier
City
Montpellier
Country
France
Facility Name
Neurologie - CHU Nancy
City
Nancy
Country
France
Facility Name
Neurochirurgie-Paris Saint Anne
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Neurologie - CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Explorations Fonctionnelles Neurologiques - CHU Nantes
City
Rennes
Country
France
Facility Name
Neurologie - CHU Rouen
City
Rouen
Country
France
Facility Name
Neurologie - CHU Tours Hopital Trousseau
City
Tours
Country
France

12. IPD Sharing Statement

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Prevention of Post-traumatic Seizures With Levetiracetam

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