Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors - Full Text View

Sponsor:	Dr Andrea Rossetti
Information provided by (Responsible Party):	Dr Andrea Rossetti, Centre Hospitalier Universitaire Vaudois
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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Anxiety Brain Cancer Cancer Seizures

Drug Information available for: Levetiracetam Pregabalin

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:

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 [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: Yes ]
Anxiety [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: No ]
Need to add a second AED [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: No ]
Study drug discontinuation [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: No ]
Occurrence of consciousness-impairing seizures or status epilepticus [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: No ]
Mortality [ Time Frame: baseline to visit at 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	February 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Levetiracetam Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year	Drug: pregabalin 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.
Active Comparator: Pregabalin Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year	Drug: levetiracetam 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.

Detailed Description:

OBJECTIVES:

To determine the safety and efficacy of antiepileptic drug monotherapy comprising levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiotherapy for primary brain tumors.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive levetiracetam.
Arm II: Patients receive pregabalin. Patients are followed at 2 weeks, 2 months, 6 months, and then at 1 year.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of primary brain tumor
- WHO grade II-IV disease
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
- No status epilepticus

PATIENT CHARACTERISTICS:

Modified Rankin score < 4 at study enrollment
Life expectancy ≥ 4 weeks
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No known intolerance to the study drugs
No pre-existing psychosis and/or current suicidality

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent IV AEDs other than benzodiazepines
Other concurrent AEDs, except phenobarbital, allowed provided they are discontinued within 2 weeks after study enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629889

Locations

Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
USZ
Zürich, Switzerland, CH-8091

Sponsors and Collaborators

Dr Andrea Rossetti

Investigators

Principal Investigator:

Andrea O. Rossetti, MD

Centre Hospitalier Universitaire Vaudois

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr Andrea Rossetti, Médecin associé, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:	NCT00629889 History of Changes
Other Study ID Numbers:	CDR0000586523, CHUV-Neurology-CePO-LEV-PGB, EU-20807
Study First Received:	March 5, 2008
Last Updated:	February 9, 2012
Health Authority:	Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:

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

Additional relevant MeSH terms:

Brain Neoplasms
Nervous System Neoplasms
Seizures
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy
Neurologic Manifestations
Signs and Symptoms
Etiracetam

Pregabalin
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012