Prevention of Post-traumatic Seizures With Levetiracetam (TRACK)
This study has been terminated.
(Sponsor decision because of to small enrollment)
Sponsor:
Rennes University Hospital
Collaborator:
UCB, Inc.
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
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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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
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:
- 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)
Contacts and Locations
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, Inc.
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 Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases 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 May 23, 2013