Prevention of Post-traumatic Seizures With Levetiracetam (TRACK)

This study has been terminated.
(Sponsor decision because of to small enrollment)
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00566046
First received: November 29, 2007
Last updated: June 20, 2012
Last verified: June 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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; safety of Levetiracetam [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Global prognosis (Glasgow Outcome Scale) [ Time Frame: 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: November 2007
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam Drug: Levetiracetam
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
Other Name: Keppra
Placebo Comparator: Placebo Drug: Placebo
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566046

Locations
France
Neurologie - CHU Angers
Angers, France
Neurology - CHU Bordeaux
Bordeaux, France
Neurologie - CHU Caen
Caen, France
Neurology - CHU Rennes
Grenoble, France
Neurochirurgie-CHU Grenoble
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, France, 75674
Neurologie - CHU Rennes
Rennes, France, 35000
Explorations Fonctionnelles Neurologiques - CHU Nantes
Rennes, France
Neurologie - CHU Rouen
Rouen, France
Neurologie - CHU Tours Hopital Trousseau
Tours, France
Sponsors and Collaborators
Rennes University Hospital
UCB Pharma
Investigators
Principal Investigator: Arnaud Biraben, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00566046     History of Changes
Other Study ID Numbers: EudraCT: 2006-006518-13, CIC0203/60, LOC/06-06
Study First Received: November 29, 2007
Last Updated: June 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014