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| Sponsors and Collaborators: |
Rennes University Hospital UCB |
|---|---|
| Information provided by: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00566046 |
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 III |
| 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 |
| 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: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient with severe brain injury defined as follow:
Exclusion Criteria:
Contacts and Locations| Contact: Arnaud Biraben, MD | arnaud.biraben@chu-rennes.fr |
| France | |
| Neurologie - CHU Rennes | Recruiting |
| Rennes, France, 35000 | |
| Contact: Arnaud Biraben, MD arnaud.biraben@chu-rennes.fr | |
| 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 |
| Study First Received: | November 29, 2007 |
| Last Updated: | October 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00566046 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Craniocerebral Trauma Nootropic Agents Seizures Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System |
Epilepsy, Post-Traumatic Brain Diseases Epilepsy Etiracetam Brain Injuries Anticonvulsants |
|
Craniocerebral Trauma Nootropic Agents Nervous System Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Epilepsy, Post-Traumatic |
Brain Diseases Pharmacologic Actions Epilepsy Therapeutic Uses Etiracetam Brain Injuries Central Nervous System Agents Anticonvulsants |