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| ID | Type | Description | Link |
|---|---|---|---|
| CHUV-Neurology-CePO-LEV-PGB | |||
| EU-20807 |
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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.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Active Comparator | Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year |
|
| Pregabalin | Active Comparator | Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levetiracetam | Drug | After inclusion, patients receive Levetiracetam 2x250mg per day. The medication may be increased, in intervals of 500mg of Levetiracetam of at least 24h up to maximally: Levetiracetam 2x1500mg. Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival without occurrence of status epilepticus, 2 seizures with consciousness impairment, need to add a second antiepileptic drug (AED) (except transitory benzodiazepine), and need to discontinue study drug for lack of efficacy or adverse events | baseline to visit at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | baseline to visit at 12 months | |
| Anxiety | baseline to visit at 12 months | |
| Need to add a second AED |
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DISEASE CHARACTERISTICS:
Diagnosis of primary brain tumor
Undergoing chemotherapy and/or radiotherapy
No brain tumor without the potential need for chemotherapy (e.g., meningioma without anaplastic features)
Has had at least one seizure provoked by the brain tumor, justifying introduction of antiepileptic drug (AED) treatment
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea O. Rossetti, MD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland | |||
| USZ |
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|
| pregabalin | Drug | After inclusion, patients receive Pregabalin 2x75mg per day. The medication may be increased, in intervals of 150mg of Pregabalin of at least 24h up to maximally: Pregabalin 2x300mg. Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study. |
|
| baseline to visit at 12 months |
| Study drug discontinuation | baseline to visit at 12 months |
| Occurrence of consciousness-impairing seizures or status epilepticus | baseline to visit at 12 months |
| Mortality | baseline to visit at 12 months |
| Zurich |
| CH-8091 |
| Switzerland |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D012640 | Seizures |
| D001254 | Astrocytoma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D018242 | Neuroectodermal Tumors, Primitive |
| D008527 | Medulloblastoma |
| D004806 | Ependymoma |
| D008579 | Meningioma |
| D009837 | Oligodendroglioma |
| D010871 | Pinealoma |
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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