Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors Seizure

Keywords

seizureadult anaplastic astrocytomaadult diffuse astrocytomaadult pineal gland astrocytomaadult glioblastomaadult gliosarcomaadult giant cell glioblastomaadult brain stem gliomaadult ependymoblastomaadult medulloblastomaadult supratentorial primitive neuroectodermal tumor (PNET)adult ependymomaadult anaplastic ependymomaadult anaplastic meningiomaadult anaplastic oligodendrogliomaadult oligodendrogliomaadult pineoblastomaadult pineocytomaadult mixed gliomaadult papillary meningiomarecurrent adult brain tumoradult grade II meningioma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

Adverse events
baseline to visit at 12 months
Anxiety
baseline to visit at 12 months

Study Arms (2)

Levetiracetam

ACTIVE COMPARATOR

Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year

Drug: pregabalin

Pregabalin

ACTIVE COMPARATOR

Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year

Drug: levetiracetam

Interventions

levetiracetamDrug

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.

Pregabalin

pregabalinDrug

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Dr Andrea Rossetti
Otherlead

Study Sites (2)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

USZ

Zurich, CH-8091, Switzerland

MeSH Terms

Conditions

Central Nervous System NeoplasmsSeizuresAstrocytomaGlioblastomaGliosarcomaNeuroectodermal Tumors, PrimitiveMedulloblastomaEpendymomaMeningiomaOligodendrogliomaPinealomaGliomaBrain Neoplasms

Interventions

LevetiracetamPregabalin

Condition Hierarchy (Ancestors)

Study Officials

Andrea O. Rossetti, MD
Centre Hospitalier Universitaire Vaudois
PRINCIPAL INVESTIGATOR

Enrollment

52 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Médecin associé

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 6, 2008

Study Start

February 2008

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Levetiracetam

Pregabalin

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Levetiracetam

Pregabalin

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations