Study Stopped
Sponsor decision because of to small enrollment
Prevention of Post-traumatic Seizures With Levetiracetam
TRACK
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
3 other identifiers
interventional
23
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2007
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 29, 2007
CompletedFirst Posted
Study publicly available on registry
November 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 21, 2012
June 1, 2012
2.1 years
November 29, 2007
June 20, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury
one year
Secondary Outcomes (2)
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
One year
Global prognosis (Glasgow Outcome Scale)
3 months, 6 months and 1 year
Study Arms (2)
Levetiracetam
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rennes University Hospitallead
- UCB Pharmacollaborator
Study Sites (15)
Neurologie - CHU Angers
Angers, France
Neurology - CHU Bordeaux
Bordeaux, France
Neurologie - CHU Caen
Caen, France
Neurochirurgie-CHU Grenoble
Grenoble, France
Neurology - CHU Rennes
Grenoble, France
Neurophysiologie Clinique - CHU Lille
Lille, France
Neurophysiologie clinique - CHU Lyon (Hôpital neurologique)
Lyon, France
Beurophysiologie clinique - CHU Marseille
Marseille, France
Epileptologie - CHU Montpellier
Montpellier, France
Neurologie - CHU Nancy
Nancy, France
Neurochirurgie-Paris Saint Anne
Paris, 75674, France
Neurologie - CHU Rennes
Rennes, 35000, France
Explorations Fonctionnelles Neurologiques - CHU Nantes
Rennes, France
Neurologie - CHU Rouen
Rouen, France
Neurologie - CHU Tours Hopital Trousseau
Tours, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud Biraben, MD
Rennes University Hospital
- STUDY CHAIR
Bruno Laviolle, MD
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2007
First Posted
November 30, 2007
Study Start
November 1, 2007
Primary Completion
December 1, 2009
Study Completion
May 1, 2010
Last Updated
June 21, 2012
Record last verified: 2012-06