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| Sponsor: | Centre Hospitalier Universitaire Vaudois |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00629889 |
Purpose
RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known which drug is more effective in treating seizures caused by primary brain tumors.
PURPOSE: This randomized phase II trial is studying the side effects and how well levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy and/or radiation therapy for primary brain tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Seizure |
Drug: levetiracetam Drug: pregabalin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label |
| Official Title: | Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study. |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary brain tumor
Has had at least one seizure provoked by the brain tumor, justifying introduction of antiepileptic drug (AED) treatment
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, Switzerland, CH-1011 | |
| Contact: Andrea O. Rossetti, MD 41-21-314-1220 | |
| Principal Investigator: | Andrea O. Rossetti, MD | Centre Hospitalier Universitaire Vaudois |
More Information
| Study ID Numbers: | CDR0000586523, CHUV-Neurology-CePO-LEV-PGB, EU-20807 |
| Study First Received: | March 5, 2008 |
| Last Updated: | November 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00629889 History of Changes |
| Health Authority: | Unspecified |
|
seizure adult anaplastic astrocytoma adult diffuse astrocytoma adult pineal gland astrocytoma adult glioblastoma adult gliosarcoma adult giant cell glioblastoma adult brain stem glioma adult ependymoblastoma adult medulloblastoma adult supratentorial primitive neuroectodermal tumor (PNET) |
adult ependymoma adult anaplastic ependymoma adult anaplastic meningioma adult anaplastic oligodendroglioma adult oligodendroglioma adult pineoblastoma adult pineocytoma adult mixed glioma adult papillary meningioma recurrent adult brain tumor adult grade II meningioma |
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Physiological Effects of Drugs Central Nervous System Neoplasms Brain Diseases Neuroprotective Agents Signs and Symptoms Neoplasms by Site Sensory System Agents Therapeutic Uses Analgesics Nervous System Neoplasms Nootropic Agents Nervous System Diseases Seizures |
Central Nervous System Diseases Pregabalin Protective Agents Pharmacologic Actions Brain Neoplasms Neoplasms Epilepsy Neurologic Manifestations Piracetam Etiracetam Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |